Minoxidil - Generic Drug Details
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What are the generic sources for minoxidil and what is the scope of patent protection?
Minoxidil
is the generic ingredient in twelve branded drugs marketed by Johnson And Johnson, Perrigo Pharma Intl, Aurobindo Pharma, P And L, Taro, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hikma, L Perrigo Co, Sight Pharms, Teva, Avacor Prods, Perrigo, Perrigo New York, Pure Source, Pfizer, Quantum Pharmics, Endo Operations, Royce Labs, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for minoxidil. One hundred and five suppliers are listed for this compound.
Summary for minoxidil
| US Patents: | 0 |
| Tradenames: | 12 |
| Applicants: | 24 |
| NDAs: | 35 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 105 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 62 |
| Patent Applications: | 6,717 |
| Drug Prices: | Drug price trends for minoxidil |
| What excipients (inactive ingredients) are in minoxidil? | minoxidil excipients list |
| DailyMed Link: | minoxidil at DailyMed |
Recent Clinical Trials for minoxidil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Industrial Farmacéutica Cantabria, S.A. | Phase 1 |
| Bioskin GmbH | Phase 3 |
| BioClever 2005 S.L. | Phase 3 |
Pharmacology for minoxidil
| Drug Class | Arteriolar Vasodilator |
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for minoxidil
Anatomical Therapeutic Chemical (ATC) Classes for minoxidil
Paragraph IV (Patent) Challenges for MINOXIDIL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| WOMEN'S ROGAINE | Topical Aerosol Foam | minoxidil | 5% | 021812 | 1 | 2015-02-04 |
| WOMEN'S ROGAINE | Topical Aerosol Foam | minoxidil | 5% | 021812 | 1 | 2009-04-06 |
US Patents and Regulatory Information for minoxidil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | MINOXIDIL (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 074589-001 | Apr 5, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sight Pharms | MINOXIDIL (FOR WOMEN) | minoxidil | SOLUTION;TOPICAL | 074743-001 | Oct 18, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sight Pharms | MINOXIDIL (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 074743-002 | Oct 18, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Royce Labs | MINOXIDIL | minoxidil | TABLET;ORAL | 071796-001 | Nov 10, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Avacor Prods | MINOXIDIL EXTRA STRENGTH (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 075619-001 | Nov 17, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo | MINOXIDIL EXTRA STRENGTH (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 075598-001 | Jun 13, 2001 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo Pharma Intl | MINOXIDIL | minoxidil | AEROSOL, FOAM;TOPICAL | 091344-001 | Apr 28, 2011 | OTC | 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 |
Expired US Patents for minoxidil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Johnson And Johnson | MEN'S ROGAINE | minoxidil | AEROSOL, FOAM;TOPICAL | 021812-001 | Jan 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | LONITEN | minoxidil | TABLET;ORAL | 018154-003 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | LONITEN | minoxidil | TABLET;ORAL | 018154-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Johnson And Johnson | WOMEN'S ROGAINE | minoxidil | AEROSOL, FOAM;TOPICAL | 021812-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
ISSN: 2162-2639
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