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Last Updated: June 23, 2024

MINOCYCLINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for minocycline hydrochloride and what is the scope of patent protection?

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, Mylan Pharms Inc, Rising, Sandoz, Sidmak Labs India, 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-four suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for MINOCYCLINE HYDROCHLORIDE

See drug prices for MINOCYCLINE HYDROCHLORIDE

Recent Clinical Trials for MINOCYCLINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Psychiatric University Hospital, ZurichN/A
University of ZurichN/A
Radboud University Medical CenterPhase 2

See all MINOCYCLINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 105MG BASETablet, Extended Release; Oral
⤷  Sign Up⤷  Sign UpEQ 80MG BASETablet, Extended Release; Oral
⤷  Sign Up⤷  Sign UpEQ 55MG 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 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET;ORAL 065156-002 Jan 6, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET;ORAL 065436-002 Dec 26, 2007 AB RX 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 Y ⤷  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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-003 May 8, 2006 ⤷  Sign Up ⤷  Sign Up
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 ⤷  Sign Up ⤷  Sign Up
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for MINOCYCLINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Canada 2799079 COMPOSITIONS DE TETRACYCLINE (TETRACYCLINE COMPOSITIONS) ⤷  Sign Up
China 102686205 Topical tetracycline compositions ⤷  Sign Up
European Patent Office 2568987 COMPOSITIONS DE TÉTRACYCLINE (TETRACYCLINE COMPOSITIONS) ⤷  Sign Up
>Country >Patent Number >Title >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.