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

Stem definitionDrug idCAS RN
antibiotics, protein-synthesis inhibitors, tetracycline derivatives 5298 1035654-66-0

Description:

MoleculeDescription

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:

DoseUnitRoute
0.10 g O

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
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:

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

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

DiseaseRelationSNOMED_IDDOID
Acne vulgaris indication 88616000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (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

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 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 60MG 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 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 60MG 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 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 60MG 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 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
EQ 60MG 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 60MG 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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

Bioactivity Summary:

None

External reference:

IDSource
94O110CX2E UNII
1035979-44-2 SECONDARY_CAS_RN
C4519292 UMLSCUI
V7A PDB_CHEM_ID
CHEMBL2364632 ChEMBL_ID
54681908 PUBCHEM_CID
DB12035 DRUGBANK_ID
CHEMBL2364633 ChEMBL_ID
D10666 KEGG_DRUG
9743 INN_ID
017779 NDDF
017780 NDDF
781643008 SNOMEDCT_US
781650007 SNOMEDCT_US
4038062 VANDF
2059018 RXNORM
294179 MMSL
35296 MMSL
d09003 MMSL
C000629276 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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