MINOCYCLINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Minocycline Hydrochloride, and what generic alternatives are available?
Minocycline Hydrochloride is a drug marketed by Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, 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, Beximco Pharms Usa, Dr Reddys Labs Ltd, Strides Pharma, Sun Pharm Industries, and Triax Pharms. and is included in twenty-seven NDAs.
The generic ingredient in MINOCYCLINE HYDROCHLORIDE is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Minocycline Hydrochloride
A generic version of MINOCYCLINE HYDROCHLORIDE was approved as minocycline hydrochloride by WATSON LABS on December 30th, 1991.
Summary for MINOCYCLINE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 23 |
NDAs: | 27 |
Finished Product Suppliers / Packagers: | 30 |
Raw Ingredient (Bulk) Api Vendors: | 95 |
Clinical Trials: | 254 |
Patent Applications: | 3,003 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MINOCYCLINE HYDROCHLORIDE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MINOCYCLINE HYDROCHLORIDE |
What excipients (inactive ingredients) are in MINOCYCLINE HYDROCHLORIDE? | MINOCYCLINE HYDROCHLORIDE excipients list |
DailyMed Link: | MINOCYCLINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for MINOCYCLINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Psychiatric University Hospital, Zurich | N/A |
University of Zurich | N/A |
Radboud University Medical Center | Phase 2 |
Pharmacology for MINOCYCLINE HYDROCHLORIDE
Drug Class | Tetracycline-class Drug |
Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for MINOCYCLINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds Ltd | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091118-007 | Dec 3, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Triax Pharms | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET;ORAL | 050451-002 | Aug 10, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Barr Labs Inc | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 065485-003 | Mar 17, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aurobindo Pharma Ltd | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202261-007 | Jun 13, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Beximco Pharms Usa | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET;ORAL | 215466-002 | May 27, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan Pharms Inc | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090911-001 | Jul 20, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sidmak Labs India | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204394-001 | Dec 30, 2015 | AB | RX | 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 |