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Last Updated: July 2, 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 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.

Recent Clinical Trials for minocycline hydrochloride

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SponsorPhase
Hotchkiss Brain Institute, University of CalgaryPhase 3
Henry Ford Health SystemN/A
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudePhase 2

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 45MG BASETABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start TrialEQ 105MG BASETablet, Extended Release; Oral
  Start Trial  Start TrialEQ 80MG BASETablet, 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
Medical Subject Heading (MeSH) Categories for minocycline hydrochloride
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

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

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

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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
Express Scripts
McKinsey

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.