Minocycline hydrochloride - Generic Drug Details
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What are the generic sources for minocycline hydrochloride and what is the scope of freedom to operate?
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, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, Rising, Sandoz, Sidmak Labs India, Sun Pharm Inds Ltd, Zydus Pharms, Epi Hlth, Dr Reddys Labs Ltd, Strides Pharma, 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-nine patent family members in twenty-seven countries.
There are fourteen drug master file entries for minocycline hydrochloride. Thirty-eight suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for minocycline hydrochloride
International Patents: | 89 |
US Patents: | 27 |
Tradenames: | 9 |
Applicants: | 29 |
NDAs: | 38 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 38 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 234 |
Patent Applications: | 4,886 |
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 |
---|---|
University of Florida | Phase 1/Phase 2 |
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1/Phase 2 |
State University of New York at Buffalo | Phase 2 |
Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 105MG BASE | Tablet, Extended Release; Oral |
See Plans and Pricing | See Plans and Pricing | EQ 80MG BASE | Tablet, Extended Release; Oral |
See Plans and Pricing | See Plans and Pricing | EQ 55MG 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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Journey | AMZEEQ | minocycline hydrochloride | AEROSOL, FOAM;TOPICAL | 212379-001 | Oct 18, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-006 | Aug 27, 2010 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Lupin Ltd | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091424-001 | Nov 30, 2011 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Aurobindo Pharma Ltd | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202261-002 | Sep 28, 2018 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-008 | Aug 27, 2010 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Aurobindo Pharma Ltd | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202261-007 | Jun 13, 2016 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | 050808-003 | May 8, 2006 | See Plans and Pricing | See Plans and Pricing |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-005 | Jul 23, 2009 | See Plans and Pricing | See Plans and Pricing |
Orapharma | ARESTIN | minocycline hydrochloride | POWDER, EXTENDED RELEASE;DENTAL | 050781-001 | Feb 16, 2001 | See Plans and Pricing | See Plans and Pricing |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-004 | Jul 23, 2009 | See Plans and Pricing | See Plans and Pricing |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-001 | May 8, 2006 | See Plans and Pricing | See Plans and Pricing |
Journey | XIMINO | minocycline hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 201922-001 | Jul 11, 2012 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for minocycline hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2013529201 | See Plans and Pricing | |
Mexico | 347919 | COMPOSICIONES DE TETRACICLINA. (TETRACYCLINE COMPOSITIONS.) | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2011039638 | See Plans and Pricing | |
Cyprus | 1114425 | See Plans and Pricing | |
Japan | 2016145253 | テトラサイクリン組成物 (TETRACYCLINE COMPOSITIONS) | See Plans and Pricing |
Mexico | 2012012993 | COMPOSICIONES DE TETRACICLINA. (TETRACYCLINE COMPOSITIONS.) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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