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Last Updated: March 28, 2024

Minoxidil - Generic Drug Details


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What are the generic drug 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 Pharma Intl, 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, 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. Ninety-seven 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
Bioskin GmbHPhase 3
BioClever 2005 S.L.Phase 3
Industrial Farmacéutica Cantabria, S.A.Phase 3

See all minoxidil clinical trials

Pharmacology for minoxidil
Drug ClassArteriolar Vasodilator
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories 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
Pure Source THEROXIDIL minoxidil SOLUTION;TOPICAL 078176-001 Nov 9, 2007 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo New York MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075737-001 Mar 15, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Johnson And Johnson ROGAINE (FOR WOMEN) minoxidil SOLUTION;TOPICAL 019501-003 Feb 9, 1996 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Johnson And Johnson WOMEN'S ROGAINE minoxidil AEROSOL, FOAM;TOPICAL 021812-002 Feb 28, 2014 ⤷  Try a Trial ⤷  Try a Trial
Pfizer LONITEN minoxidil TABLET;ORAL 018154-003 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>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.