SARECYCLINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for sarecycline hydrochloride and what is the scope of patent protection?

Sarecycline hydrochloride is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sarecycline hydrochloride has seventy-one patent family members in twenty countries.

One supplier is listed for this compound.

Summary for SARECYCLINE HYDROCHLORIDE

International Patents:	71
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	6
Patent Applications:	12
What excipients (inactive ingredients) are in SARECYCLINE HYDROCHLORIDE?	SARECYCLINE HYDROCHLORIDE excipients list
DailyMed Link:	SARECYCLINE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SARECYCLINE HYDROCHLORIDE

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 SARECYCLINE HYDROCHLORIDE

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

Sponsor	Phase
Beijing Tiantan Hospital	Phase 2
NeuroDawn Pharmaceutical Co., Ltd.	Phase 2
Derm Research, PLLC	Phase 4

See all SARECYCLINE HYDROCHLORIDE clinical trials

Pharmacology for SARECYCLINE HYDROCHLORIDE

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

US Patents and Regulatory Information for SARECYCLINE HYDROCHLORIDE

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	209521-003	Oct 1, 2018		RX	Yes	Yes			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			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-001	Oct 1, 2018		RX	Yes	No

International Patents for SARECYCLINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	2009006846	DERIVADOS DE TETRACICLINA PARA EL TRATAMIENTO DE INFECCIONES BACTERIANAS, VIRALES Y PARASITARIAS. (SUBSTITUTED TETRACYCLINE COMPOUNDS.)
European Patent Office	2455367	Dérivés de tétracycline pour le traitement d'infections bactériennes, virales et parasites (Tetracycline derivatives for the treatment of bacterial, viral and parasitic infections)
Poland	2707003
Canada	2892739	UTILISATION DE COMPOSES A BASE DE TETRACYCLINE SUBSTITUEE DANS LE TRAITEMENT D'AFFECTIONS CUTANEES INFLAMMATOIRES (SUBSTITUTED TETRACYCLINE COMPOUNDS FOR TREATMENT OF INFLAMMATORY SKIN DISORDERS)
Turkey	201911086
Japan	2019081802	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 DERIVATIVES FOR TREATMENT OF BACTERIAL, VIRAL AND PARASITIC INFECTIONS)
Denmark	2707003