Minocycline hydrochloride - Generic Drug Details

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 Journey, Alvogen, Bausch, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Lederle, Rempex, Nexus Pharms, Orapharma, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, Rising, Sandoz, Sidmak Labs India, Sun Pharm Inds Ltd, Zydus Pharms, Epi Hlth, Beximco Pharms Usa, Dr Reddys Labs Ltd, Strides Pharma, and Sun Pharm Industries, and is included in forty 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-nine patent family members in twenty-seven countries.

There are fourteen drug master file entries for minocycline hydrochloride. Thirty-nine suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for minocycline hydrochloride

International Patents:	89
US Patents:	27
Tradenames:	9
Applicants:	31
NDAs:	40
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	248
Patent Applications:	4,905
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
William Damsky	Phase 2
Yale University	Phase 2
Research Foundation Flanders	Phase 3

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 115MG BASE	TABLET, EXTENDED RELEASE; ORAL
		EQ 65MG BASE	TABLET, EXTENDED RELEASE; ORAL
		EQ 135MG 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 Tetracycline-class Drug
Physiological Effect	Decreased Prothrombin Activity

Medical Subject Heading (MeSH) Categories for minocycline hydrochloride

Anti-Bacterial Agents

Paragraph IV (Patent) Challenges for MINOCYCLINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZILXI	Topical Aerosol Foam	minocycline hydrochloride	1.50%	213690	1	2022-02-28
AMZEEQ	Topical Aerosol Foam	minocycline hydrochloride	4%	212379	1	2021-05-11
MINOCIN	Injection	minocycline hydrochloride	100 mg/vial	050444	1	2020-10-16
SOLODYN	Extended-release Tablet	minocycline hydrochloride	105 mg	050808	1	2010-12-13
SOLODYN	Extended-release Tablet	minocycline hydrochloride	55 mg	050808	1	2010-12-02
SOLODYN	Extended-release Tablet	minocycline hydrochloride	80 mg	050808	1	2010-10-27
SOLODYN	Extended-release Tablet	minocycline hydrochloride	65 mg and 115 mg	050808	1	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
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-002	May 8, 2006		DISCN	Yes	No
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-003	May 8, 2006		DISCN	Yes	No
Sandoz	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090422-002	Aug 13, 2009	AB	RX	No	No
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes
Alkem Labs Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204453-004	Sep 28, 2016	AB	RX	No	No
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-007	Aug 27, 2010	AB	RX	Yes	No
Aurobindo Pharma Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202261-008	Aug 21, 2019	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	050808-001	May 8, 2006
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-004	Jul 23, 2009
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-007	Aug 27, 2010
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-003	May 8, 2006
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-006	Aug 27, 2010

International Patents for minocycline hydrochloride

Country	Patent Number	Title	Estimated Expiration
Norway	20080444
United Kingdom	201016546
Australia	2011252919	Tetracycline compositions
World Intellectual Property Organization (WIPO)	2011039637
China	101208097	Method for the treatment of acne
Israel	188331
World Intellectual Property Organization (WIPO)	2011039638