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Minocycline hydrochloride - Generic Drug Details

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

Minocycline hydrochloride is the generic ingredient in nine branded drugs marketed by Vyne, Journey, Alvogen, Bausch, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Lederle, Rempex, Orapharma, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin Ltd, Mylan, Mylan Labs Ltd, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Sun Pharm Inds Ltd, Zydus Pharms, Epi Hlth, Dr Reddys Labs Ltd, Par Pharm, and Sun Pharm Industries, and is included in thirty-eight NDAs. There are twenty-seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Minocycline hydrochloride has eighty-eight patent family members in twenty-seven countries.

There are fifteen drug master file entries for minocycline hydrochloride. Thirty-eight suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for minocycline hydrochloride

International Patents:	88
US Patents:	27
Tradenames:	9
Applicants:	31
NDAs:	38
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	223
Patent Applications:	3,198
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for minocycline hydrochloride
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for minocycline hydrochloride
What excipients (inactive ingredients) are in minocycline hydrochloride?	minocycline hydrochloride excipients list
DailyMed Link:	minocycline hydrochloride at DailyMed

See drug prices for minocycline hydrochloride

Recent Clinical Trials for minocycline hydrochloride

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

Sponsor	Phase
Cutia Therapeutics (Shanghai) Co., Ltd	Phase 3
Vyne Therapeutics Inc.	Phase 4
Edward Lain, MD	Phase 4

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 135MG BASE	TABLET, EXTENDED RELEASE;ORAL
		EQ 90MG BASE	TABLET, EXTENDED RELEASE;ORAL
		EQ 45MG BASE	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for minocycline hydrochloride

Drug Class

Tetracycline-class Drug

Medical Subject Heading (MeSH) Categories for minocycline hydrochloride

Anti-Bacterial Agents

Paragraph IV (Patent) Challenges for MINOCYCLINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
AMZEEQ	AEROSOL, FOAM;TOPICAL	minocycline hydrochloride	212379	2021-05-11
MINOCIN	INJECTABLE;INJECTION	minocycline hydrochloride	050444	2020-10-16
SOLODYN	TABLET, EXTENDED RELEASE;ORAL	minocycline hydrochloride	050808	2010-12-13
SOLODYN	TABLET, EXTENDED RELEASE;ORAL	minocycline hydrochloride	050808	2010-12-02
SOLODYN	TABLET, EXTENDED RELEASE;ORAL	minocycline hydrochloride	050808	2010-10-27
SOLODYN	TABLET, EXTENDED RELEASE;ORAL	minocycline hydrochloride	050808	2009-11-19

US Patents and Regulatory Information for minocycline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090024-002	Feb 3, 2009		DISCN	No	No
Torrent	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	CAPSULE;ORAL	065062-002	Nov 30, 2000	AB	RX	No	No
Impax Labs	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	CAPSULE;ORAL	065005-002	Mar 23, 1999	AB	RX	No	No

Expired US Patents for minocycline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-004	Jul 23, 2009
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-001	May 8, 2006

International Patents for minocycline hydrochloride

Country	Patent Number	Estimated Expiration
Japan	2005521467
Slovenia	2263596
European Patent Office	3135289