Details for New Drug Application (NDA): 209521
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NDA 209521 describes SEYSARA, which is a drug marketed by Almirall and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SEYSARA profile page.
The generic ingredient in SEYSARA is sarecycline hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sarecycline hydrochloride profile page.
The generic ingredient in SEYSARA is sarecycline hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sarecycline hydrochloride profile page.
Summary for 209521
| Tradename: | SEYSARA |
| Applicant: | Almirall |
| Ingredient: | sarecycline hydrochloride |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209521
Generic Entry Date for 209521*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 209521
| Mechanism of Action | P-Glycoprotein Inhibitors |
Suppliers and Packaging for NDA: 209521
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521 | NDA | Almirall, LLC | 16110-245 | 16110-245-30 | 30 TABLET, COATED in 1 BOTTLE (16110-245-30) |
| SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521 | NDA | Almirall, LLC | 16110-246 | 16110-246-30 | 30 TABLET, COATED in 1 BOTTLE (16110-246-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Oct 1, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 8,318,706 | Patent Expiration: | Jan 3, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | 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 | ||||||||
| Patent: | 8,513,223 | Patent Expiration: | Dec 7, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | 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 | ||||||||
| Patent: | 9,255,068 | Patent Expiration: | Feb 9, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | 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 | ||||||||
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