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 eight branded drugs marketed by Foamix, Journey, Cnty Line Pharms, Bausch, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Lederle, Rempex Pharms, 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, Medicis, Dr Reddys Labs Ltd, Par Pharm, and Sun Pharm Industries, and is included in thirty-seven NDAs. There are twenty-two 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-nine suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for minocycline hydrochloride

International Patents:	88
US Patents:	22
Tradenames:	8
Applicants:	32
NDAs:	37
Drug Master File Entries:	15
Suppliers / Packagers:	39
Bulk Api Vendors:	78
Clinical Trials:	207
Patent Applications:	2,930
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for minocycline hydrochloride
DailyMed Link:	minocycline hydrochloride at DailyMed

Recent Clinical Trials for minocycline hydrochloride

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Sponsor	Phase
Hotchkiss Brain Institute, University of Calgary	Phase 3
Henry Ford Health System	N/A
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude	Phase 2

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	EQ 45MG BASE	TABLET, EXTENDED RELEASE;ORAL
Start Trial	Start Trial	EQ 105MG BASE	Tablet, Extended Release; Oral
Start Trial	Start Trial	EQ 80MG 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
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

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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
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-002	May 8, 2006		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-008	Aug 27, 2010	AB	RX	Yes	No	Start Trial	Start Trial				Start Trial
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Foamix	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Torrent	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	CAPSULE;ORAL	065062-001	Nov 30, 2000	AB	RX	No	No	Start Trial	Start Trial				Start Trial
>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
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009	Start Trial	Start Trial
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-002	May 8, 2006	Start Trial	Start Trial
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012	Start Trial	Start Trial
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012	Start Trial	Start Trial
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-003	May 8, 2006	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for minocycline hydrochloride

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Country	Patent Number	Estimated Expiration
Brazil	112012007473	Start Trial
Canada	2776474	Start Trial
China	101208097	Start Trial
Denmark	2568987	Start Trial
Israel	218865	Start Trial
>Country	>Patent Number	>Estimated Expiration

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