Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
tyrosine kinase inhibitors	5393	2152628-33-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: selpercatinib retevmo LOXO-292 LY3527723	Selpercatinib is a kinase inhibitor. Selpercatinib inhibited wild-type RET and multiple mutated RET isoforms as well as VEGFR1 and VEGFR3 with IC50 values ranging from 0.92 nM to 67.8 nM. In other enzyme assays, selpercatinib also inhibited FGFR 1, 2, and 3 at higher concentrations that were still clinically achievable. In cellular assays, selpercatinib inhibited RET at approximately 60-fold lower concentrations than FGFR1 and 2 and approximately 8-fold lower concentration than VEGFR3 Molecular weight: 525.61 Formula: C29H31N7O3 CLOGP: 3.21 LIPINSKI: 1 HAC: 10 HDO: 1 TPSA: 112.04 ALOGS: -4.25 ROTB: 8 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

selpercatinib
retevmo
LOXO-292
LY3527723

Selpercatinib is a kinase inhibitor. Selpercatinib inhibited wild-type RET and multiple mutated RET isoforms as well as VEGFR1 and VEGFR3 with IC50 values ranging from 0.92 nM to 67.8 nM. In other enzyme assays, selpercatinib also inhibited FGFR 1, 2, and 3 at higher concentrations that were still clinically achievable. In cellular assays, selpercatinib inhibited RET at approximately 60-fold lower concentrations than FGFR1 and 2 and approximately 8-fold lower concentration than VEGFR3

Molecular weight: 525.61
Formula: C29H31N7O3
CLOGP: 3.21
LIPINSKI: 1
HAC: 10
HDO: 1
TPSA: 112.04
ALOGS: -4.25
ROTB: 8

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.32	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value
kinase-safety-class	ACVR2B,AXL,CAMK2D,EIF2AK3,GAK,IRAK1,IRAK3,KDR,LCK,NTRK1,PDK1,PDK2,PDK4,PIK3CA,PIK3CD,PRKDC	16
kinase-selectivity-class	CAMK2D,EGFR,EIF2AK3,FLT3,GAK,INSR,IRAK1,IRAK3,KDR,LRRK2,MAP3K7,MAP4K1,MAP4K3,MINK1,NTRK1,NUAK1,PDK1,SIK2	18
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company
May 8, 2020	FDA	LOXO ONCOLOGY INC
Feb. 11, 2021	EMA	Eli Lilly Nederland B.V.
Sept. 27, 2021	PMDA	ELI LILLY JAPAN K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	137.64	43.21	45	648	106825	90520929
Tumour associated fever	61.51	43.21	9	684	460	90627294
Febrile infection	48.17	43.21	9	684	2060	90625694
Urinary tract infection enterococcal	44.78	43.21	9	684	3007	90624747

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	124.71	38.38	47	768	174520	110413964
Tumour associated fever	53.68	38.38	9	806	1152	110587332
Urinary tract infection enterococcal	43.27	38.38	9	806	3693	110584791
Electrocardiogram QT prolonged	42.12	38.38	19	796	108941	110479543
Febrile infection	41.62	38.38	9	806	4439	110584045

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01EX22	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Other protein kinase inhibitors
FDA EPC	N0000175605	Kinase Inhibitor
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000187062	Cytochrome P450 2C8 Inhibitors
FDA MoA	N0000190113	Breast Cancer Resistance Protein Inhibitors
FDA MoA	N0000190114	Cytochrome P450 3A Inhibitors
FDA MoA	N0000191423	Multidrug and Toxin Extrusion Transporter 1 Inhibitors
FDA MoA	N0000193947	Rearranged during Transfection (RET) Inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agent

Related Drugs by ATC class:

L01EX Other protein kinase inhibitors 21 drugs

avapritinib cabozantinib capivasertib entrectinib gilteritinib larotrectinib lenvatinib midostaurin nintedanib pazopanib pexidartinib pralsetinib show all 21 →

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Advanced RET fusion-positive non-small cell lung cancer	indication	254637007	DOID:3908
Medullary thyroid carcinoma	indication	255032005	DOID:3973
Metastasis from malignant tumor of thyroid	indication	315007008
Advanced RET fusion-positive thyroid cancer	indication	363478007	DOID:1781
Metastatic non-small cell lung cancer	indication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10137124	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10172851	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10137124	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10172851	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10137124	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	10172851	Oct. 10, 2037	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10584124	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10584124	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10584124	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10584124	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10786489	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10786489	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10786489	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10786489	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	12138250	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10584124	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10584124	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10584124	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10584124	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10786489	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10786489	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10786489	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	10786489	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	12138250	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	12138250	Oct. 10, 2038	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 8, 2027	ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 8, 2027	INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 8, 2027	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 8, 2027	ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 8, 2027	INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 8, 2027	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	May 8, 2027	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	May 8, 2027	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	May 8, 2027	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	May 8, 2027	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 29, 2027	NEW PATIENT POPULATION
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 29, 2027	NEW PATIENT POPULATION
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-431
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-531
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-431
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-531
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-431
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-531
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-431
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-531
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-431
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-531
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-431
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 27, 2027	REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-531
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Nov. 8, 2027	PEDIATRIC EXCLUSIVITY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Nov. 8, 2027	PEDIATRIC EXCLUSIVITY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Nov. 8, 2027	PEDIATRIC EXCLUSIVITY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Nov. 8, 2027	PEDIATRIC EXCLUSIVITY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Nov. 8, 2027	PEDIATRIC EXCLUSIVITY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Nov. 8, 2027	PEDIATRIC EXCLUSIVITY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Nov. 29, 2027	PEDIATRIC EXCLUSIVITY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Nov. 29, 2027	PEDIATRIC EXCLUSIVITY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	March 27, 2028	PEDIATRIC EXCLUSIVITY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	March 27, 2028	PEDIATRIC EXCLUSIVITY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	March 27, 2028	PEDIATRIC EXCLUSIVITY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	March 27, 2028	PEDIATRIC EXCLUSIVITY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	March 27, 2028	PEDIATRIC EXCLUSIVITY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	March 27, 2028	PEDIATRIC EXCLUSIVITY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Sept. 21, 2029	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Sept. 21, 2029	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAVE PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Sept. 21, 2029	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Sept. 21, 2029	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAVE PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 21, 2029	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 21, 2029	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 21, 2029	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Sept. 21, 2029	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	March 21, 2030	PEDIATRIC EXCLUSIVITY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	March 21, 2030	PEDIATRIC EXCLUSIVITY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	March 21, 2030	PEDIATRIC EXCLUSIVITY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	March 21, 2030	PEDIATRIC EXCLUSIVITY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	March 21, 2030	PEDIATRIC EXCLUSIVITY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	March 21, 2030	PEDIATRIC EXCLUSIVITY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 29, 2031	TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, THAT HAVE PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 29, 2031	TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 29, 2031	TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 29, 2031	TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, THAT HAVE PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 29, 2031	TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	May 29, 2031	TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	May 29, 2031	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	May 29, 2031	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	May 29, 2031	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	May 29, 2031	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
40MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Nov. 29, 2031	PEDIATRIC EXCLUSIVITY
80MG	RETEVMO	ELI LILLY AND CO	N213246	May 8, 2020	RX	CAPSULE	ORAL	Nov. 29, 2031	PEDIATRIC EXCLUSIVITY
120MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Nov. 29, 2031	PEDIATRIC EXCLUSIVITY
160MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Nov. 29, 2031	PEDIATRIC EXCLUSIVITY
40MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Nov. 29, 2031	PEDIATRIC EXCLUSIVITY
80MG	RETEVMO	ELI LILLY AND CO	N218160	April 10, 2024	RX	TABLET	ORAL	Nov. 29, 2031	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Proto-oncogene tyrosine-protein kinase receptor Ret	Kinase	P07949	RET_HUMAN	INHIBITOR	IC50	7.76	DRUG LABEL	DRUG LABEL
Aurora kinase B	Kinase	Q96GD4	AURKB_HUMAN	INHIBITOR	IC50	7.10	DRUG LABEL
Vascular endothelial growth factor receptor 2	Kinase	P35968	VGFR2_HUMAN		IC50	7	CHEMBL

External reference:

ID	Source
D11713	KEGG_DRUG
CEGM9YBNGD	UNII
4039392	VANDF
C5235396	UMLSCUI
CHEBI:757714	CHEBI
Q6G	PDB_CHEM_ID
CHEMBL4559134	ChEMBL_ID
134436906	PUBCHEM_CID
DB15685	DRUGBANK_ID
10967	INN_ID
C000656166	MESH_SUPPLEMENTAL_RECORD_UI
10318	IUPHAR_LIGAND_ID
876841001	SNOMEDCT_US
876867006	SNOMEDCT_US
334353	MMSL
38465	MMSL
d09562	MMSL
018362	NDDF
2370147	RXNORM
CEGM9YBNGD	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
RETEVMO	HUMAN PRESCRIPTION DRUG LABEL	1	0002-2980	CAPSULE	80 mg	ORAL	NDA	32 sections
RETEVMO	HUMAN PRESCRIPTION DRUG LABEL	1	0002-3977	CAPSULE	40 mg	ORAL	NDA	32 sections
RETEVMO	HUMAN PRESCRIPTION DRUG LABEL	1	0002-5340	TABLET, COATED	40 mg	ORAL	NDA	32 sections
RETEVMO	HUMAN PRESCRIPTION DRUG LABEL	1	0002-5562	TABLET, COATED	160 mg	ORAL	NDA	32 sections
RETEVMO	HUMAN PRESCRIPTION DRUG LABEL	1	0002-6082	TABLET, COATED	80 mg	ORAL	NDA	32 sections
RETEVMO	HUMAN PRESCRIPTION DRUG LABEL	1	0002-6120	TABLET, COATED	120 mg	ORAL	NDA	32 sections

Ask DrugCentral

Try a sample question

selpercatinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

Drug Use | Suggest Off label Use Form| |View source of the data|

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: