Sarecycline hydrochloride - Generic Drug Details

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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

Generic Entry Date for sarecycline hydrochloride^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
NeuroDawn Pharmaceutical Co., Ltd.	Phase 2
Beijing Tiantan Hospital	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

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Glossary

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

International Patents for sarecycline hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Japan	2023093519	（４Ｓ，４ＡＳ，５ＡＲ，１２ＡＳ）－４－ジメチルアミノ－３，１０，１２，１２Ａ－テトラヒドロキシ－７－［（メトキシ（メチル）アミノ）－メチル］－１，１１－ジオキソ－１，４，４Ａ，５，５Ａ，６，１１，１２Ａ－オクタヒドロ－ナフタセン－２－カルボン酸アミドの結晶塩及びそれを使用する方法 (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-2-CARBOXYLIC ACID AMIDE, AND METHODS OF USING THE SAME)	⤷ Sign Up
Poland	2707003		⤷ Sign Up
Croatia	P20191295		⤷ Sign Up
Denmark	2109602		⤷ Sign Up
Poland	2109602		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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