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Last Updated: January 30, 2023

Minocycline hydrochloride - Generic Drug Details


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What are the generic 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, Nexus Pharms, 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 forty 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-nine suppliers are listed for this compound. There are four 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
William DamskyPhase 2
Yale UniversityPhase 2
Research Foundation FlandersPhase 3

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 115MG BASETABLET, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and PricingEQ 65MG BASETABLET, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and PricingEQ 135MG 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
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-002 May 8, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-003 May 8, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 090422-002 Aug 13, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Journey ZILXI minocycline hydrochloride AEROSOL, FOAM;TOPICAL 213690-001 May 28, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 204453-004 Sep 28, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-007 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 202261-008 Aug 21, 2019 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 050808-001 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
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 050808-007 Aug 27, 2010 See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-003 May 8, 2006 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 050808-006 Aug 27, 2010 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
Norway 20080444 See Plans and Pricing
United Kingdom 201016546 See Plans and Pricing
Australia 2011252919 Tetracycline compositions See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011039637 See Plans and Pricing
China 101208097 Method for the treatment of acne See Plans and Pricing
Israel 188331 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011039638 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Boehringer Ingelheim
Colorcon
AstraZeneca
Johnson and Johnson

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.