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 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, Chartwell Rx, Impax Labs Inc, Norvium Bioscience, Rising, Sandoz, Sun Pharm, 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-six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Minocycline hydrochloride has sixty-eight patent family members in twenty-four countries.

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

Summary for minocycline hydrochloride

International Patents:	68
US Patents:	26
Tradenames:	9
Applicants:	31
NDAs:	40
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	258
Patent Applications:	4,500
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
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)	Phase 1/Phase 2
Pontificia Universidad Catolica de Chile	Phase 1/Phase 2
Maimonides Medical Center	Phase 2/Phase 3

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Subscribe	⤷ Subscribe	EQ 135MG BASE	TABLET, EXTENDED RELEASE;ORAL
⤷ Subscribe	⤷ Subscribe	EQ 90MG BASE	TABLET, EXTENDED RELEASE;ORAL
⤷ Subscribe	⤷ Subscribe	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
Physiological Effect	Decreased Prothrombin Activity

Medical Subject Heading (MeSH) Categories for minocycline hydrochloride

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for minocycline hydrochloride

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

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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
Watson Labs	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	CAPSULE;ORAL	063065-001	Dec 30, 1991	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Torrent	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	CAPSULE;ORAL	065062-002	Nov 30, 2000	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-007	Aug 27, 2010		DISCN	Yes	No	7,919,483	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for minocycline hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001	6,682,348	⤷ Subscribe
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012	5,908,838	⤷ Subscribe
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-001	May 8, 2006	5,908,838	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for minocycline hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Mexico	359879	COMPOSICIONES TÓPICAS DE TETRACICLINA. (TOPICAL TETRACYCLINE COMPOSITIONS.)	⤷ Subscribe
Israel	218865	תכשירי טטרציקלין לשימוש מקומי (Topical tetracycline compositions)	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2011143503		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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