Minocycline hydrochloride - Generic Drug Details

What are the generic sources for minocycline hydrochloride and what is the scope of freedom to operate?

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, 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, Dr Reddys Labs Ltd, Strides Pharma, 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-nine patent family members in twenty-seven countries.

There are fourteen 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:	89
US Patents:	27
Tradenames:	9
Applicants:	29
NDAs:	38
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	234
Patent Applications:	4,886
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
University of Florida	Phase 1/Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1/Phase 2
State University of New York at Buffalo	Phase 2

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 105MG BASE	Tablet, Extended Release; Oral
		EQ 80MG BASE	Tablet, Extended Release; Oral
		EQ 55MG 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

Anatomical Therapeutic Chemical (ATC) Classes for minocycline hydrochloride

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

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

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
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes			Y
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-006	Aug 27, 2010	AB	RX	Yes	No
Lupin Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	091424-001	Nov 30, 2011	AB	RX	No	No
Aurobindo Pharma Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202261-002	Sep 28, 2018	AB	RX	No	No
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-008	Aug 27, 2010	AB	RX	Yes	No
Aurobindo Pharma Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202261-007	Jun 13, 2016	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	050808-003	May 8, 2006
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-004	Jul 23, 2009
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

International Patents for minocycline hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2013529201
Mexico	347919	COMPOSICIONES DE TETRACICLINA. (TETRACYCLINE COMPOSITIONS.)
World Intellectual Property Organization (WIPO)	2011039638
Cyprus	1114425
Japan	2016145253	テトラサイクリン組成物 (TETRACYCLINE COMPOSITIONS)
Mexico	2012012993	COMPOSICIONES DE TETRACICLINA. (TETRACYCLINE COMPOSITIONS.)