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.
Summary for minocycline hydrochloride
International Patents: | 89 |
US Patents: | 27 |
Tradenames: | 9 |
Applicants: | 31 |
NDAs: | 40 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 39 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 248 |
Patent Applications: | 4,905 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
William Damsky | Phase 2 |
Yale University | Phase 2 |
Research Foundation Flanders | Phase 3 |
Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 115MG BASE | TABLET, EXTENDED RELEASE; ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 65MG BASE | TABLET, EXTENDED RELEASE; ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 135MG BASE | TABLET, 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
Drug Class | Tetracycline-class Drug Tetracycline-class Drug |
Physiological Effect | Decreased Prothrombin Activity |
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
Expired US Patents for minocycline hydrochloride
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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