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, Norvium Bioscience, Rising, Sandoz, Sun Pharm, 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-two 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.
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Questions you can ask:
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Summary for MINOCYCLINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 23 |
| NDAs: | 27 |
| Finished Product Suppliers / Packagers: | 29 |
| Raw Ingredient (Bulk) Api Vendors: | 95 |
| Clinical Trials: | 258 |
| Patent Applications: | 2,826 |
| 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 |
|---|---|
| Pontificia Universidad Catolica de Chile | Phase 1/Phase 2 |
| Liga Panamericana de Asociaciones de Reumatologia (PANLAR) | Phase 1/Phase 2 |
| Maimonides Medical Center | Phase 2/Phase 3 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Triax Pharms | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET;ORAL | 050451-002 | Aug 10, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Barr Labs Inc | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 065485-003 | Mar 17, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma Ltd | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202261-007 | Jun 13, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
