sarecycline 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antibiotics, protein-synthesis inhibitors, tetracycline derivatives	5298	1035654-66-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: sarecycline sarecycline hydrochloride seysara P005672 P0005672 WC-3035	The mechanism of action of sarecycline in treating acne vulgaris is not known. Molecular weight: 487.51 Formula: C24H29N3O8 CLOGP: -0.13 LIPINSKI: 1 HAC: 11 HDO: 5 TPSA: 173.86 ALOGS: -2.39 ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

sarecycline
sarecycline hydrochloride
seysara
P005672
P0005672
WC-3035

The mechanism of action of sarecycline in treating acne vulgaris is not known.

Molecular weight: 487.51
Formula: C24H29N3O8
CLOGP: -0.13
LIPINSKI: 1
HAC: 11
HDO: 5
TPSA: 173.86
ALOGS: -2.39
ROTB: 5

Status: ONP

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

Drug dosage:

Dose	Unit	Route
0.10	g	O

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ
S (Water solubility)	14 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
Oct. 1, 2018	FDA	ALLERGAN INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J01AA14	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE TETRACYCLINES Tetracyclines
FDA CS	M0021223	Tetracyclines
FDA EPC	N0000175882	Tetracycline-class Drug
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D003879	Dermatologic Agents

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

Disease	Relation	SNOMED_ID	DOID
Acne vulgaris	indication	88616000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.13	acidic
pKa2	8.56	acidic
pKa3	10.08	acidic
pKa4	11.96	acidic
pKa5	13.08	acidic
pKa6	9.41	Basic
pKa7	2.23	Basic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 100MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	9481639	Aug. 10, 2028	A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING SARECYCLINE HYDROCHLORIDE IN 60 MG, 100 MG OR 150 MG EQUIVALENT DOSES
EQ 100MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	8513223	Dec. 7, 2029	A METHOD FOR TREATING A PATIENT 9 YEARS OF AGE AND OLDER SUFFERING FROM AN INFLAMMATORY SKIN DISORDER OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE
EQ 100MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	8318706	May 1, 2031	A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE
EQ 100MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	9255068	Feb. 9, 2033	A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT
EQ 100MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	9255068	Feb. 9, 2033	A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT
EQ 150MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	9481639	Aug. 10, 2028	A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING SARECYCLINE HYDROCHLORIDE IN 60 MG, 100 MG OR 150 MG EQUIVALENT DOSES
EQ 150MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	8513223	Dec. 7, 2029	A METHOD FOR TREATING A PATIENT 9 YEARS OF AGE AND OLDER SUFFERING FROM AN INFLAMMATORY SKIN DISORDER OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE
EQ 150MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	8318706	May 1, 2031	A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE
EQ 150MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	9255068	Feb. 9, 2033	A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT
EQ 150MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	9255068	Feb. 9, 2033	A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 100MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	Oct. 1, 2023	NEW CHEMICAL ENTITY
EQ 150MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	Oct. 1, 2023	NEW CHEMICAL ENTITY
EQ 60MG BASE	SEYSARA	ALMIRALL	N209521	Oct. 1, 2018	RX	TABLET	ORAL	Oct. 1, 2023	NEW CHEMICAL ENTITY

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Bioactivity Summary:

None

External reference:

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ID	Source
V7A	PDB_CHEM_ID
017779	NDDF
017780	NDDF
1035979-44-2	SECONDARY_CAS_RN
2059018	RXNORM
294179	MMSL
35296	MMSL
4038062	VANDF
54681908	PUBCHEM_CID
781643008	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Seysara	HUMAN PRESCRIPTION DRUG LABEL	1	16110-245	TABLET, COATED	60 mg	ORAL	NDA	29 sections
Seysara	HUMAN PRESCRIPTION DRUG LABEL	1	16110-245	TABLET, COATED	60 mg	ORAL	NDA	29 sections
Seysara	HUMAN PRESCRIPTION DRUG LABEL	1	16110-246	TABLET, COATED	100 mg	ORAL	NDA	29 sections
Seysara	HUMAN PRESCRIPTION DRUG LABEL	1	16110-246	TABLET, COATED	100 mg	ORAL	NDA	29 sections
Seysara	HUMAN PRESCRIPTION DRUG LABEL	1	16110-247	TABLET, COATED	150 mg	ORAL	NDA	29 sections
Seysara	HUMAN PRESCRIPTION DRUG LABEL	1	16110-247	TABLET, COATED	150 mg	ORAL	NDA	29 sections

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