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Last Updated: March 29, 2024

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 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, Impax Labs Inc, Lupin Ltd, 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-five 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-six 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
⤷  Try a Trial⤷  Try a TrialEQ 105MG BASETablet, Extended Release; Oral
⤷  Try a Trial⤷  Try a TrialEQ 80MG BASETablet, Extended Release; Oral
⤷  Try a Trial⤷  Try a TrialEQ 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
Journey ZILXI minocycline hydrochloride AEROSOL, FOAM;TOPICAL 213690-001 May 28, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-003 Jul 11, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-003 May 8, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-003 May 8, 2006 ⤷  Try a Trial ⤷  Try a Trial
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-001 Jul 11, 2012 ⤷  Try a Trial ⤷  Try a Trial
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-008 Aug 27, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for minocycline hydrochloride

Country Patent Number Title Estimated Expiration
Canada 2867419 UTILISATION DE COMPOSITIONS DE TETRACYCLINE POUR LE TRAITEMENT DES BLESSURES ET LA RESTAURATION DE LA PEAU (USE OF TETRACYCLINE COMPOSITIONS FOR WOUND TREATMENT AND SKIN RESTORATION) ⤷  Try a Trial
Mexico 347919 COMPOSICIONES DE TETRACICLINA. (TETRACYCLINE COMPOSITIONS.) ⤷  Try a Trial
Poland 2568987 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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