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Last Updated: June 27, 2022

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, Dr Reddys Labs Ltd, Strides Pharma, and Sun Pharm Industries, and is included in thirty-eight NDAs. There are twenty-seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Minocycline hydrochloride has eighty-nine patent family members in twenty-seven countries.

There are fourteen drug master file entries for minocycline hydrochloride. Thirty-eight suppliers are listed for this compound. There are five 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
University of FloridaPhase 1/Phase 2
National Heart, Lung, and Blood Institute (NHLBI)Phase 1/Phase 2
State University of New York at BuffaloPhase 2

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 105MG BASETablet, Extended Release; Oral
See Plans and PricingSee Plans and PricingEQ 80MG BASETablet, Extended Release; Oral
See Plans and PricingSee Plans and PricingEQ 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 AMZEEQ minocycline hydrochloride AEROSOL, FOAM;TOPICAL 212379-001 Oct 18, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 091424-001 Nov 30, 2011 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 202261-002 Sep 28, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-008 Aug 27, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 202261-007 Jun 13, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 See Plans and Pricing See Plans and Pricing
Orapharma ARESTIN minocycline hydrochloride POWDER, EXTENDED RELEASE;DENTAL 050781-001 Feb 16, 2001 See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-004 Jul 23, 2009 See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 See Plans and Pricing See Plans and Pricing
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-001 Jul 11, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for minocycline hydrochloride

Country Patent Number Title Estimated Expiration
Japan 2013529201 See Plans and Pricing
Mexico 347919 COMPOSICIONES DE TETRACICLINA. (TETRACYCLINE COMPOSITIONS.) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011039638 See Plans and Pricing
Cyprus 1114425 See Plans and Pricing
Japan 2016145253 テトラサイクリン組成物 (TETRACYCLINE COMPOSITIONS) See Plans and Pricing
Mexico 2012012993 COMPOSICIONES DE TETRACICLINA. (TETRACYCLINE COMPOSITIONS.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Dow
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Express Scripts
McKinsey

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