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Last Updated: October 26, 2020

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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 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-eight NDAs. There are twenty-three 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-eight suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for minocycline hydrochloride

International Patents:	88
US Patents:	23
Tradenames:	9
Applicants:	32
NDAs:	38
Drug Master File Entries:	15
Suppliers / Packagers:	38
Bulk Api Vendors:	76
Clinical Trials:	210
Patent Applications:	2,980
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
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
Royal Perth Hospital	Phase 3
Hotchkiss Brain Institute, University of Calgary	Phase 3
Henry Ford Health System	N/A

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 105MG BASE	Tablet, Extended Release; Oral
Start Trial	Start Trial	EQ 80MG BASE	Tablet, Extended Release; Oral
Start Trial	Start Trial	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

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	050808-007	Aug 27, 2010	AB	RX	Yes	No	Start Trial	Start Trial				Start Trial
Triax Pharms	MINOCIN	minocycline hydrochloride	CAPSULE;ORAL	050315-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Dr Reddys Labs Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET;ORAL	065436-001	Dec 26, 2007	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012		RX	No	No	Start Trial	Start Trial				Start Trial
Mylan Pharms Inc	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090911-003	Jul 20, 2010		DISCN	No	No	Start Trial	Start Trial				Start Trial
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012		RX	No	No	Start Trial	Start Trial	Y			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	050808-002	May 8, 2006	Start Trial	Start Trial
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012	Start Trial	Start Trial
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-003	May 8, 2006	Start Trial	Start Trial
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	050808-004	Jul 23, 2009	Start Trial	Start Trial
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-007	Aug 27, 2010	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
Mexico	2017011630	Start Trial
World Intellectual Property Organization (WIPO)	2011064631	Start Trial
Israel	222896	Start Trial
Mexico	2012012993	Start Trial
Australia	2015224534	Start Trial
Japan	6290298	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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