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Last Updated: August 6, 2020

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MINOXIDIL Drug Profile

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Which patents cover Minoxidil, and what generic alternatives are available?

Minoxidil is a drug marketed by Perrigo Israel, Par Pharm, Royce Labs, Sun Pharm Industries, Usl Pharma, Watson Labs, 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, and Perrigo New York. and is included in twenty-six NDAs.

The generic ingredient in MINOXIDIL is minoxidil. There are eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

US ANDA Litigation and Generic Entry Outlook for Minoxidil

A generic version of MINOXIDIL was approved as minoxidil by WATSON LABS on March 3rd, 1987.

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Drug patent expirations by year for MINOXIDIL
Drug Prices for MINOXIDIL

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Recent Clinical Trials for MINOXIDIL

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SponsorPhase
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
WOMEN'S ROGAINE AEROSOL, FOAM;TOPICAL minoxidil 021812 2009-04-06
MEN'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
Perrigo New York MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075737-001 Mar 15, 2002 OTC No No   Start Trial   Start Trial   Start Trial
Apotex Inc MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075839-001 Oct 1, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Wockhardt Bio Ag MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075438-001 Feb 27, 2003 OTC No No   Start Trial   Start Trial   Start Trial
Avacor Prods MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075619-001 Nov 17, 2000 OTC No No   Start Trial   Start Trial   Start Trial
Perrigo Israel MINOXIDIL minoxidil AEROSOL, FOAM;TOPICAL 091344-001 Apr 28, 2011 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

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