SEYSARA Drug Patent Profile

When do Seysara patents expire, and when can generic versions of Seysara launch?

Seysara is a drug marketed by Almirall and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-seven patent family members in twenty countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Seysara

Seysara was eligible for patent challenges on October 1, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 9, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SEYSARA

International Patents:	67
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	1
Patent Applications:	99
Drug Prices:	Drug price information for SEYSARA
What excipients (inactive ingredients) are in SEYSARA?	SEYSARA excipients list
DailyMed Link:	SEYSARA at DailyMed

See drug prices for SEYSARA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for SEYSARA

NDA:

209521

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.

Recent Clinical Trials for SEYSARA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Derm Research, PLLC	Phase 4

See all SEYSARA clinical trials

Pharmacology for SEYSARA

Drug Class	Tetracycline-class Drug
Mechanism of Action	P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SEYSARA

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for SEYSARA

SEYSARA is protected by five US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SEYSARA

FDA Regulatory Exclusivity protecting SEYSARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-001	Oct 1, 2018		RX	Yes	No
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-001	Oct 1, 2018		RX	Yes	No			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes

International Patents for SEYSARA

When does loss-of-exclusivity occur for SEYSARA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Croatia

Denmark

European Patent Office

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SEYSARA around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	234755	נגזרות טטרציקלין לטיפול בדלקות חיידקיות, נגיפיות וטפיליות (Tetracycline derivatives for the treatment of bacterial, viral and parasitic infections)
Lithuania	2120963
Canada	2673486	UTILISATION DE COMPOSES A BASE DE TETRACYCLINE SUBSTITUEE DANS LE TRAITEMENT D'AFFECTIONS CUTANEES INFLAMMATOIRES (SUBSTITUTED TETRACYCLINE COMPOUNDS FOR TREATMENT OF INFLAMMATORY SKIN DISORDERS)
Japan	2015205939	細菌感染、ウイルス感染、および寄生虫感染の治療のためのテトラサイクリン誘導体 (TETRACYCLINE DERIVATIVE FOR TREATMENT OF BACTERIA INFECTION, VIRUS INFECTION AND PARASITE INFECTION)
European Patent Office	3488853	COMPOSÉS DE TÉTRACYCLINE SUBSTITUÉS POUR LE TRAITEMENT DE TROUBLES INFLAMMATOIRES DE LA PEAU (SUBSTITUTED TETRACYCLINE COMPOUNDS FOR TREATMENT OF INFLAMMATORY SKIN DISORDERS)
European Patent Office	2109602	DERIVÉS DE LA TETRACYCLINE POUR LE TRAITEMENT DE INFECTIONS BACTERIELLES, VIRALES ET PARASITIQUES (TETRACYCLINE DERIVATIVES FOR THE TREATMENT OF BACTERIAL, VIRAL AND PARASITIC INFECTIONS)
Poland	2109602