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Last Updated: July 26, 2021

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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 freedom to operate?

Minoxidil is the generic ingredient in twelve branded drugs marketed by Johnson And Johnson, Perrigo Israel, P And L, Taro, Akorn, Apotex Inc, Bausch And Lomb, Copley Pharm, L Perrigo Co, Sight Pharms, Teva, Wockhardt Bio Ag, Avacor Prods, Perrigo, Perrigo New York, Ei Inc, Pfizer, 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. Forty-four 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

SponsorPhase
Eurofarma Laboratorios S.A.Phase 3
Gregory L Smith, MD, MPHEarly Phase 1
Cairo UniversityPhase 2/Phase 3

See all minoxidil clinical trials

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
Wockhardt Bio Ag MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075438-001 Feb 27, 2003 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Ei Inc THEROXIDIL minoxidil SOLUTION;TOPICAL 078176-001 Nov 9, 2007 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Johnson And Johnson WOMEN'S ROGAINE minoxidil AEROSOL, FOAM;TOPICAL 021812-002 Feb 28, 2014 OTC Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sight Pharms MINOXIDIL (FOR WOMEN) minoxidil SOLUTION;TOPICAL 074743-001 Oct 18, 1996 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer LONITEN minoxidil TABLET;ORAL 018154-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer LONITEN minoxidil TABLET;ORAL 018154-003 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Johnson And Johnson WOMEN'S ROGAINE minoxidil AEROSOL, FOAM;TOPICAL 021812-002 Feb 28, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Baxter
Harvard Business School
Boehringer Ingelheim
McKesson

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