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Last Updated: October 24, 2021

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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 Vyne, 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, Mylan Labs Ltd, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Sun Pharm Inds Ltd, Zydus Pharms, Epi Hlth, Dr Reddys Labs Ltd, Par Pharm, 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-eight patent family members in twenty-seven countries.

There are fifteen 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

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Recent Clinical Trials for minocycline hydrochloride

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

SponsorPhase
Cutia Therapeutics (Shanghai) Co., LtdPhase 3
Vyne Therapeutics Inc.Phase 4
Edward Lain, MDPhase 4

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever TrialEQ 135MG BASETABLET, EXTENDED RELEASE;ORAL
⤷  Free Forever Trial⤷  Free Forever TrialEQ 90MG BASETABLET, EXTENDED RELEASE;ORAL
⤷  Free Forever Trial⤷  Free Forever 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 NDA Submissiondate
AMZEEQ AEROSOL, FOAM;TOPICAL minocycline hydrochloride 212379 2021-05-11
MINOCIN INJECTABLE;INJECTION minocycline hydrochloride 050444 2020-10-16
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-12-13
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-12-02
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-10-27
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 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
Impax Labs Inc MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 090024-002 Feb 3, 2009 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Torrent MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 065062-002 Nov 30, 2000 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Impax Labs MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 065005-002 Mar 23, 1999 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-005 Jul 11, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.