You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 13, 2024

Minocycline hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, 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-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-five 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 135MG BASETABLET, EXTENDED RELEASE;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 90MG BASETABLET, EXTENDED RELEASE;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 45MG 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 050808-004 Jul 23, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Ltd MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 091118-004 Sep 25, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 204453-006 Mar 16, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 203553-003 Jun 16, 2023 DISCN No 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 050808-004 Jul 23, 2009 ⤷  Try a Trial ⤷  Try a Trial
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-003 Jul 11, 2012 ⤷  Try a Trial ⤷  Try a Trial
Orapharma ARESTIN minocycline hydrochloride POWDER, EXTENDED RELEASE;DENTAL 050781-001 Feb 16, 2001 ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

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.