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Last Updated: August 12, 2020

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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 Israel, P And L, Taro, Apotex Inc, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, L Perrigo Co, Sight Pharms, Teva, Wockhardt Bio Ag, Avacor Prods, Perrigo, Perrigo New York, Ei Inc, Pharmacia And Upjohn, Quantum Pharmics, Par Pharm, Royce Labs, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for minoxidil. Thirty-nine suppliers are listed for this compound.

Drug Prices for MINOXIDIL

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Recent Clinical Trials for MINOXIDIL

Identify potential brand extensions & 505(b)(2) entrants

University of Minnesota - Clinical and Translational Science InstitutePhase 2
Northwestern UniversityEarly Phase 1
Institute of Dermatology, ThailandPhase 4

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Pharmacology for MINOXIDIL
Medical Subject Heading (MeSH) Categories for MINOXIDIL
Paragraph IV (Patent) Challenges for MINOXIDIL
Tradename Dosage Ingredient NDA Submissiondate
MEN'S ROGAINE AEROSOL, FOAM;TOPICAL minoxidil 021812 2009-04-06
WOMEN'S ROGAINE AEROSOL, FOAM;TOPICAL minoxidil 021812 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
Avacor Prods MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075619-001 Nov 17, 2000 OTC No No   Start Trial   Start Trial   Start Trial
Apotex Inc MINOXIDIL (FOR WOMEN) minoxidil SOLUTION;TOPICAL 074924-002 Apr 29, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Taro MINOXIDIL (FOR WOMEN) minoxidil AEROSOL, FOAM;TOPICAL 209074-002 Apr 22, 2019 OTC No No   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Pharmacia And Upjohn LONITEN minoxidil TABLET;ORAL 018154-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Johnson And Johnson WOMEN'S ROGAINE minoxidil AEROSOL, FOAM;TOPICAL 021812-002 Feb 28, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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