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Serving leading biopharmaceutical companies globally:

Chubb
Dow
Cantor Fitzgerald
McKinsey
AstraZeneca
Merck
Healthtrust
Queensland Health
Fuji
Fish and Richardson

Generated: February 25, 2018

DrugPatentWatch Database Preview

Minocycline hydrochloride - Generic Drug Details

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

Minocycline hydrochloride
is the generic ingredient in seven branded drugs marketed by Sun Pharm Inds Ltd, Cnty Line Pharms, Precision Dermat, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent Pharma Inc, Watson Labs, Watson Labs Teva, Zydus Worldwide, Lederle, Rempex Pharms, Orapharma, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Medicis, Par Pharm, and Sun Pharm Industries, and is included in thirty-four NDAs. There are thirteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Minocycline hydrochloride has fifty-four patent family members in twenty-six countries.

There are thirteen drug master file entries for minocycline hydrochloride. Fifty-four suppliers are listed for this compound. There are seven tentative approvals for this compound.
Summary for minocycline hydrochloride
Pharmacology for minocycline hydrochloride
Ingredient-typeTetracyclines
Drug ClassTetracycline-class Drug
Medical Subject Heading (MeSH) Categories for minocycline hydrochloride
Tentative approvals for MINOCYCLINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 45MG BASETABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign UpEQ 135MG BASETABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign UpEQ 115MG BASETABLET, EXTENDED RELEASE;ORAL

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
Barr Labs Inc MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 065485-008 Apr 26, 2017 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 203553-008 Nov 16, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-003 Jul 11, 2012 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-002 Jul 11, 2012 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 091424-004 Nov 30, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cnty Line Pharms DYNACIN minocycline hydrochloride CAPSULE;ORAL 063067-003 Aug 14, 1990 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Par Pharm MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET;ORAL 065131-001 Apr 16, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 090422-003 Aug 13, 2009 AB RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-005 Jul 11, 2012 RX No No ➤ 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

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Expired US Patents for minocycline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-001 Jul 11, 2012 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-003 May 8, 2006 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-002 May 8, 2006 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-003 Jul 11, 2012 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-004 Jul 23, 2009 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-007 Aug 27, 2010 ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-005 Jul 11, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for minocycline hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,744,179 Tetracycline compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for minocycline hydrochloride

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Cantor Fitzgerald
Colorcon
Mallinckrodt
Federal Trade Commission
Chubb
Fuji
Medtronic

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 verifification 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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