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 |
|---|---|
|
Synonyms:
|
The mechanism of action of sarecycline in treating acne vulgaris is not known.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.10 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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:
| 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:
| Source | Code | Description |
|---|---|---|
| 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|
| 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
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 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 |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 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:
| 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 |