Sarecycline hydrochloride - Generic Drug Details

What are the generic 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

Anatomical Therapeutic Chemical (ATC) Classes for sarecycline hydrochloride

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

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	209521-001	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
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

International Patents for sarecycline hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2010513527
European Patent Office	3574908	SELS CRISTALLINS D'AMIDE DE L'ACIDE (4S,4AS,5AR,12AS)-4-DIMÉTHYLAMINO- 3,10,12,12A-TÉTRAHYDROXY-7-[(MÉTHOXY(MÉTHYL)AMINO)-MÉTHYL]- 1,11-DIOXO-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-NAPHTACÈNE-2-CARBOXYLIQUE ET PROCÉDÉS D'UTILISATION ASSOCIÉS (CRYSTALLINE SALTS OF (4S, 4AS, 5AR, 12AS)-4-DIMETHYLAMINO-3,10,12,12A-TETRAHYDROXY-7-[(METHOXY(METHYL)AMINO)-METHYL]-1,11-DIOXO-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-NAPHTHACENE-2CARBOXYLIC ACID AMIDE AND METHODS OF USING THE SAME)
Israel	302749	תרכובת טטראציקלין, תכשיר פרמצבטי המכיל את התרכובת הטטראציקלין, והתרכובת הטטראציקלין או התכשיר הפרמצבטי לטיפול במצב המגיב לטטראציקלין (A tetracycline compound, a pharmaceutical composition comprising the tetracycline compound, and the tetracycline compound of the pharmaceutical composition for treating a tetracycline responsive state)
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)
World Intellectual Property Organization (WIPO)	2008079339