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Last Updated: April 18, 2024

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. 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 ActionP-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:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Oct 1, 2018TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:May 1, 2031Product Flag?YSubstance Flag?YDelist 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:⤷  Try a TrialPatent Expiration:Dec 7, 2029Product 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:⤷  Try a TrialPatent Expiration:Feb 9, 2033Product Flag?YSubstance Flag?YDelist 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.