Minocycline hydrochloride - Generic Drug Details

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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, 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 thirty-nine 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-two 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:	30
NDAs:	39
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	258
Patent Applications:	4,345
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
Pontificia Universidad Catolica de Chile	Phase 1/Phase 2
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)	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
⤷ Sign Up	⤷ Sign Up	EQ 55MG BASE	TABLET, EXTENDED RELEASE; ORAL
⤷ Sign Up	⤷ Sign Up	EQ 115MG BASE	TABLET, EXTENDED RELEASE; ORAL
⤷ Sign Up	⤷ Sign Up	EQ 65MG 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
Zydus Pharms	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203553-001	Nov 16, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-007	Aug 27, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Beximco Pharms Usa	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET;ORAL	215466-001	May 27, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET;ORAL	090217-002	Jan 29, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009	⤷ Sign Up	⤷ Sign Up
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012	⤷ Sign Up	⤷ Sign Up
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012	⤷ Sign Up	⤷ Sign Up
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-008	Aug 27, 2010	⤷ Sign Up	⤷ Sign Up
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001	⤷ Sign Up	⤷ Sign Up
>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
Canada	2776474	COMPOSITIONS DE TETRACYCLINE A USAGE TOPIQUE (TOPICAL TETRACYCLINE COMPOSITIONS)	⤷ Sign Up
Chile	2012003168	Composicion farmaceutica que comprende una solucion acuosa de minociclina y un cation divalente o trivalente en una proporcion mayor de 2:1 con respecto a la minociclina; metodo de preparacion; kit y uso en el tratamiento de infecciones bacterianas.	⤷ Sign Up
Canada	2776366	COMPOSITIONS MOUSSANTES SANS EAU ET SANS SURFACTANT, MOUSSES ET GELS FRIABLES, AINSI QUE LEURS UTILISATIONS (SURFACTANT-FREE WATER-FREE FOAMABLE COMPOSITIONS, BREAKABLE FOAMS AND GELS AND THEIR USES)	⤷ Sign Up
Canada	2776471	COMPOSITIONS MOUSSANTES DEPOURVUES D'AGENT TENSIOACTIF ET D'EAU ET MOUSSES CASSABLES ET LEURS UTILISATIONS (SURFACTANT-FREE, WATER-FREE, FOAMABLE COMPOSITIONS AND BREAKABLE FOAMS AND THEIR USES)	⤷ Sign Up
Australia	2006262428	Method for the treatment of acne	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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