Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
cystic fibrosis transmembrane regulator (CFTR) protein modulators, correctors, and amplifiers	5276	1152311-62-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: tezacaftor VX-661	Tezacaftor facilitates the cellular processing and trafficking of normal and select mutant forms of CFTR (including F508del-CFTR) to increase the amount of mature CFTR protein delivered to the cell surface. Molecular weight: 520.51 Formula: C26H27F3N2O6 CLOGP: 2.78 LIPINSKI: 1 HAC: 8 HDO: 4 TPSA: 113.18 ALOGS: -4.62 ROTB: 8 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

tezacaftor
VX-661

Tezacaftor facilitates the cellular processing and trafficking of normal and select mutant forms of CFTR (including F508del-CFTR) to increase the amount of mature CFTR protein delivered to the cell surface.

Molecular weight: 520.51
Formula: C26H27F3N2O6
CLOGP: 2.78
LIPINSKI: 1
HAC: 8
HDO: 4
TPSA: 113.18
ALOGS: -4.62
ROTB: 8

Status: ONP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value
kinase-safety-class	EIF2AK3,GRK2,PDK1,PDK2,PDK4	5
kinase-selectivity-class	EIF2AK3,PDK1	2
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
Aug. 21, 2020	EMA	Vertex Pharmaceuticals (Ireland) Limited
Feb. 12, 2018	FDA	VERTEX PHARMS

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
Pelvic kidney	78.61	62.20	7	24	106	90628310

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R07AX31	RESPIRATORY SYSTEM OTHER RESPIRATORY SYSTEM PRODUCTS OTHER RESPIRATORY SYSTEM PRODUCTS Other respiratory system products
ATC	R07AX32	RESPIRATORY SYSTEM OTHER RESPIRATORY SYSTEM PRODUCTS OTHER RESPIRATORY SYSTEM PRODUCTS Other respiratory system products
ATC	R07AX33	RESPIRATORY SYSTEM OTHER RESPIRATORY SYSTEM PRODUCTS OTHER RESPIRATORY SYSTEM PRODUCTS Other respiratory system products

Related Drugs by ATC class:

R07AX Other respiratory system products 6 drugs

deutivacaftor elexacaftor ivacaftor lumacaftor nitric oxide vanzacaftor

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

Disease	Relation	SNOMED_ID	DOID
Cystic fibrosis of the lung	indication	86555001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.64	acidic
pKa2	13.25	acidic
pKa3	13.99	acidic

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
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	8354427	July 6, 2026	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	8354427	July 6, 2026	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8354427	July 6, 2026	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8354427	July 6, 2026	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	9670163	Dec. 28, 2026	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	9931334	Dec. 28, 2026	TREATING CYSTIC FIBROSIS PATIENTS AGES 12 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (<30% CRYSTALLINE) IVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	9931334	Dec. 28, 2026	TREATING CYSTIC FIBROSIS PATIENTS AGES 6 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (<30% CRYSTALLINE) IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	9670163	Dec. 28, 2026	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	9931334	Dec. 28, 2026	TREATING CYSTIC FIBROSIS PATIENTS AGES 12 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (<30% CRYSTALLINE) IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	9931334	Dec. 28, 2026	TREATING CYSTIC FIBROSIS PATIENTS AGES 6 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (<30% CRYSTALLINE) IVACAFTOR
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9670163	Dec. 28, 2026	TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9670163	Dec. 28, 2026	TREATMENT OF CF WITH VNZ/TEZ AND A COMP. OF CLAIM 1 OF US9670163 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9931334	Dec. 28, 2026	TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9931334	Dec. 28, 2026	TREATMENT OF CF WITH VNZ/TEZ AND A COMP. RECITED IN CLAIM 1 OF US9931334 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9670163	Dec. 28, 2026	TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9670163	Dec. 28, 2026	TREATMENT OF CF WITH VNZ/TEZ AND A COMP. OF CLAIM 1 OF US9670163 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9931334	Dec. 28, 2026	TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9931334	Dec. 28, 2026	TREATMENT OF CF WITH VNZ/TEZ AND A COMP. RECITED IN CLAIM 1 OF US9931334 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10022352	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10022352	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10239867	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10239867	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	11639347	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	9974781	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	9974781	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10022352	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10022352	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10239867	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10239867	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	11639347	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	9974781	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	9974781	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10022352	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10239867	April 9, 2027	TREATMENT OF CF WITH VNZ, TEZ, D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10239867	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11639347	April 9, 2027	TREATMENT OF CF WITH VNZ, TEZ, D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11639347	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9974781	April 9, 2027	TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9974781	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10022352	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10239867	April 9, 2027	TREATMENT OF CF WITH VNZ, TEZ, D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10239867	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11639347	April 9, 2027	TREATMENT OF CF WITH VNZ, TEZ, D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11639347	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9974781	April 9, 2027	TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9974781	April 9, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	8598181	May 1, 2027	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	8598181	May 1, 2027	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8598181	May 1, 2027	TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8598181	May 1, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8598181	May 1, 2027	TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8598181	May 1, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	8324242	Aug. 5, 2027	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	8324242	Aug. 5, 2027	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8324242	Aug. 5, 2027	TREATMENT OF CF WITH VNZ, TEZ, D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8324242	Aug. 5, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8324242	Aug. 5, 2027	TREATMENT OF CF WITH VNZ, TEZ, D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8324242	Aug. 5, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	8415387	Nov. 12, 2027	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	8415387	Nov. 12, 2027	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8415387	Nov. 12, 2027	TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8415387	Nov. 12, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8415387	Nov. 12, 2027	TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	8415387	Nov. 12, 2027	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	11564916	Aug. 13, 2029	TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	12458635	Aug. 13, 2029	TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	11564916	Aug. 13, 2029	TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	12458635	Aug. 13, 2029	TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11564916	Aug. 13, 2029	TREATMENT OF CF WITH VNZ/TEZ AND A COMP. RECITED IN CLAIM 1 OF US11564916 IN CF PATIENTS AGED ≥6 Y WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11564916	Aug. 13, 2029	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11564916, VNZ, AND TEZ
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11564916	Aug. 13, 2029	TREATMENT OF CF WITH VNZ/TEZ AND A COMP. RECITED IN CLAIM 1 OF US11564916 IN CF PATIENTS AGED ≥6 Y WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11564916	Aug. 13, 2029	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11564916, VNZ, AND TEZ
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10081621	March 25, 2031	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10081621	March 25, 2031	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	11578062	March 25, 2031	TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11578062 CLAIM 6 OR 13
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10081621	March 25, 2031	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10081621	March 25, 2031	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	11578062	March 25, 2031	TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11578062 CLAIM 6 OR 13
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10081621	March 25, 2031	TREATMENT OF CF WITH VNZ, D-IVA, AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10081621	March 25, 2031	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ, D-IVA, AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10081621
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11578062	March 25, 2031	TREATMENT OF CF WITH VNZ, D-IVA, AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS AGED ≥6 Y WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11578062	March 25, 2031	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, DEUTIVACAFTOR, AND A SOLID DISPERSION ACCORDING TO CLAIM 1 OF US 11,578,062
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10081621	March 25, 2031	TREATMENT OF CF WITH VNZ, D-IVA, AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10081621	March 25, 2031	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ, D-IVA, AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10081621
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11578062	March 25, 2031	TREATMENT OF CF WITH VNZ, D-IVA, AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS AGED ≥6 Y WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11578062	March 25, 2031	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, DEUTIVACAFTOR, AND A SOLID DISPERSION ACCORDING TO CLAIM 1 OF US 11,578,062
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9181192	May 17, 2032	TREATING CF WITH VNZ/TEZ AND A D-IVA COMP. WITH 90%+ ISOTOPIC ENRICHMENT FOR EACH D ATOM IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR PRODUCES CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9181192	May 17, 2032	TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING VNZ, TEZ, AND D-IVA WITH AT LEAST 90% ISOTOPIC ENRICHMENT FOR EACH DEUTERIUM ATOM
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9512079	May 17, 2032	TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VNZ, TEZ, AND A COMPOSITION ACCORDING TO CLAIM 3 OF US 9,512,079
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9512079	May 17, 2032	TREATMENT OF CF WITH VNZ/TEZ AND A COMP. OF CLAIM 3 OF US9512079 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9181192	May 17, 2032	TREATING CF WITH VNZ/TEZ AND A D-IVA COMP. WITH 90%+ ISOTOPIC ENRICHMENT FOR EACH D ATOM IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR PRODUCES CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9181192	May 17, 2032	TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING VNZ, TEZ, AND D-IVA WITH AT LEAST 90% ISOTOPIC ENRICHMENT FOR EACH DEUTERIUM ATOM
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9512079	May 17, 2032	TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VNZ, TEZ, AND A COMPOSITION ACCORDING TO CLAIM 3 OF US 9,512,079
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9512079	May 17, 2032	TREATMENT OF CF WITH VNZ/TEZ AND A COMP. OF CLAIM 3 OF US9512079 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10058546	July 15, 2033	TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10058546	July 15, 2033	TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	9012496	July 15, 2033	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR THE F508DEL MUTATION AND A SECOND MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10058546	July 15, 2033	TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10058546	July 15, 2033	TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	9012496	July 15, 2033	TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR THE F508DEL MUTATION AND A SECOND MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10058546	July 15, 2033	TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WITH AT LEAST ONE F508DEL OR G551D AND AN R117H, A455E, 2789+5G->A, OR 3849+10KBC->T CFTR MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF US10058546 CLAIM 1 FURTHER COMPRISING VNZ
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	9012496	July 15, 2033	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 9,012,496 FURTHER COMPRISING VNZ
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10206877	April 14, 2035	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	10206877	April 14, 2035	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	11951212	April 14, 2035	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 11951212
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10206877	April 14, 2035	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	10206877	April 14, 2035	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10206877	April 14, 2035	TREATMENT OF CF WITH VNZ AND A COMP. OF CLAIM 1 OF US10206877 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	10206877	April 14, 2035	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10206877
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11951212	April 14, 2035	TREATMENT OF CF WITH VNZ AND A COMP. OF CLAIM 1 OF US11951212 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11951212	April 14, 2035	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ AND A COMPOSITION ACCORDING TO CLAIM 1 OF US11951212
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11866450	Feb. 14, 2039	TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11866450	Feb. 14, 2039	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11866450	Feb. 14, 2039	TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11866450	Feb. 14, 2039	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11873300	Aug. 13, 2040	TREATMENT OF CF WITH VNZ CA SALT HYDRATE FORM D, TEZ, AND D-IVA IN CF PATIENTS AGED 6 YEARS AND OLDER WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11873300	Aug. 13, 2040	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR CALCIUM SALT HYDRATE FORM D, TEZACAFTOR, AND DEUTIVACAFTOR
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11873300	Aug. 13, 2040	TREATMENT OF CF WITH VNZ CA SALT HYDRATE FORM D, TEZ, AND D-IVA IN CF PATIENTS AGED 6 YEARS AND OLDER WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	11873300	Aug. 13, 2040	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR CALCIUM SALT HYDRATE FORM D, TEZACAFTOR, AND DEUTIVACAFTOR
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	12186306	Jan. 10, 2043	TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH 21.4 MG OF VNZ CALCIUM SALT HYDRATE FORM D, 100 MG OF TEZ, AND 250 MG OF D-IVA DAILY
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	12186306	Jan. 10, 2043	TREATMENT OF CF WITH VNZ CA SALT HYDRATE FORM D/TEZ/D-IVA (21.24/100/250 MG) IN CF PATIENTS AGED ≥6 Y WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	June 21, 2026	TX OF PTS W/ CYSTIC FIBROSIS (CF) AGE 6 TO <12 YRS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR W/ AT LEAST 1 MUTATION IN CF TRANSMEMBRANE CONDUCTANCE REGULATORY GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	June 21, 2026	TX OF PTS W/ CYSTIC FIBROSIS (CF) AGE 6 TO <12 YRS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR W/ AT LEAST 1 MUTATION IN CF TRANSMEMBRANE CONDUCTANCE REGULATORY GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
150MG;150MG, 100MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	Feb. 12, 2018	RX	TABLET	ORAL	Dec. 21, 2027	FOR TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AT LEAST ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
75MG;75MG, 50MG	SYMDEKO (COPACKAGED)	VERTEX PHARMS INC	N210491	June 21, 2019	RX	TABLET	ORAL	Dec. 21, 2027	FOR TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AT LEAST ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	Dec. 20, 2029	NEW CHEMICAL ENTITY
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	Dec. 20, 2029	NEW CHEMICAL ENTITY
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	Dec. 20, 2031	TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 6 YEARS OF AGE AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	Dec. 20, 2031	TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 6 YEARS OF AGE AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
125MG;50MG;EQ 10MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	March 27, 2033	TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IS IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY THE PREVIOUS APPROVAL FOR ALYFTREK ON DECEMBER 20, 2024
50MG;20MG;EQ 4MG BASE	ALYFTREK	VERTEX PHARMS INC	N218730	Dec. 20, 2024	RX	TABLET	ORAL	March 27, 2033	TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IS IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY THE PREVIOUS APPROVAL FOR ALYFTREK ON DECEMBER 20, 2024

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Cystic fibrosis transmembrane conductance regulator	Ion channel	P13569	CFTR_HUMAN	PHARMACOLOGICAL CHAPERONE	EC50	6.57		CHEMBL	DRUG LABEL

External reference:

ID	Source
8RW88Y506K	UNII
4037327	VANDF
C4519194	UMLSCUI
CHEBI:234517	CHEBI
CV6	PDB_CHEM_ID
CHEMBL3544914	ChEMBL_ID
46199646	PUBCHEM_CID
DB11712	DRUGBANK_ID
D11041	KEGG_DRUG
10104	INN_ID
C000625213	MESH_SUPPLEMENTAL_RECORD_UI
10199	IUPHAR_LIGAND_ID
771596001	SNOMEDCT_US
33763	MMSL
d08742	MMSL
017465	NDDF
1999382	RXNORM
8RW88Y506K	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ALYFTREK	HUMAN PRESCRIPTION DRUG LABEL	3	51167-121	TABLET, FILM COATED	50 mg	ORAL	NDA	33 sections
ALYFTREK	HUMAN PRESCRIPTION DRUG LABEL	3	51167-135	TABLET, FILM COATED	20 mg	ORAL	NDA	33 sections

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tezacaftor 🐶 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):

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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:

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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: