Is there a generic for Minoxidil?

Yes. The FDA Orange Book lists 33 approved generic (ANDA) applications for Minoxidil, referencing the brand MEN'S ROGAINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Minoxidil?

MEN'S ROGAINE (NDA 021812, KENVUE BRANDS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Minoxidil are approved?

Minoxidil is approved in the following dosage forms: aerosol, foam, solution, tablet.

FDA Orange Book · active-ingredient family

Minoxidil

Minoxidil: 4 brands, 33 generics; first approved Mar 03, 1987; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 33 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

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MEN'S ROGAINERLDRS
KENVUE BRANDSNDA 02181220062 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% AEROSOL, FOAM TOPICAL OTC -
5% AEROSOL, FOAM TOPICAL OTC -
ROGAINE EXTRA STRENGTH (FOR MEN)RLDRS
KENVUE BRANDSNDA 0208341997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL OTC -
ROGAINE (FOR MEN)RLDRS
KENVUE BRANDSNDA 01950119962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL OTC -
2% SOLUTION TOPICAL OTC -
LONITENRLD
PFIZERNDA 018154-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	AEROSOL, FOAM	TOPICAL	OTC	-
5%	AEROSOL, FOAM	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	OTC	-
2%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-
10MG	TABLET	ORAL	Discontinued	-

Generic (ANDA) products (33)

Abbreviated applications

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MINOXIDIL EXTRA STRENGTH (FOR MEN)
TAROANDA 2179982025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL OTC -
MINOXIDIL (FOR WOMEN)
TAROANDA 2181752024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL OTC -
MINOXIDIL (FOR MEN)
AUROBINDO PHARMAANDA 21861620242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% AEROSOL, FOAM TOPICAL OTC -
5% AEROSOL, FOAM TOPICAL OTC -
MINOXIDIL (FOR MEN)
TAROANDA 20907420182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% AEROSOL, FOAM TOPICAL OTC -
5% AEROSOL, FOAM TOPICAL OTC -
MINOXIDIL (FOR MEN)
P AND LANDA 20809220172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% AEROSOL, FOAM TOPICAL OTC -
5% AEROSOL, FOAM TOPICAL OTC -
MINOXIDIL
PERRIGO PHARMA INTLANDA 0913442011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% AEROSOL, FOAM TOPICAL OTC -
THEROXIDIL
PURE SOURCEANDA 0781762007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL OTC -
THEROXIDIL
PURE SOURCEANDA 0762392004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL OTC -
MINOXIDIL EXTRA STRENGTH (FOR MEN)
AUROBINDO PHARMA LTDANDA 0754382003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL OTC -
MINOXIDIL EXTRA STRENGTH (FOR MEN)
PERRIGO NEW YORKANDA 0757372002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL Discontinued -
MINOXIDIL EXTRA STRENGTH (FOR MEN)
APOTEX INCANDA 0758392001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL Discontinued -
MINOXIDIL EXTRA STRENGTH (FOR MEN)
PERRIGOANDA 0755982001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL OTC -
MINOXIDIL EXTRA STRENGTH (FOR MEN)
AVACOR PRODSANDA 0756192000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL Discontinued -
MINOXIDIL EXTRA STRENGTH (FOR MEN)
P AND LANDA 0755182000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL OTC -
MINOXIDIL (FOR MEN)
L PERRIGO COANDA 07535719992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL OTC -
2% SOLUTION TOPICAL OTC -
MINOXIDIL (FOR MEN)
APOTEX INCANDA 07492419982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued -
2% SOLUTION TOPICAL Discontinued -
MINOXIDIL (FOR MEN)
AUROBINDO PHARMA LTDANDA 07476719972 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL OTC -
2% SOLUTION TOPICAL OTC -
MINOXIDIL (FOR MEN)
HIKMAANDA 07473119962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued -
2% SOLUTION TOPICAL Discontinued -
MINOXIDIL (FOR MEN)
SIGHT PHARMSANDA 07474319962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued -
2% SOLUTION TOPICAL Discontinued -
MINOXIDIL (FOR MEN)
COPLEY PHARMANDA 0745001996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued -
MINOXIDIL (FOR MEN)
BAUSCH AND LOMBANDA 0746431996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued -
MINOXIDIL (FOR MEN)
P AND LANDA 0745881996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL OTC -
MINOXIDIL (FOR MEN)
TEVAANDA 0745891996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued -
MINOXIDIL
SUN PHARM INDUSTRIESANDA 07270919952 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
2.5MG TABLET ORAL Rx AB
MINOXIDIL
USL PHARMAANDA 0715371988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
MINOXIDIL
PH HEALTHANDA 0718261988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
MINOXIDIL
PH HEALTHANDA 0718391988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
MINODYL
QUANTUM PHARMICSANDA 0721531988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
MINOXIDIL
ROYCE LABSANDA 0717991987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
MINOXIDIL
ROYCE LABSANDA 0717961987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued -
MINODYL
QUANTUM PHARMICSANDA 0715341987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued -
MINOXIDIL
WATSON LABSANDA 0713441987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
MINOXIDILRS
WATSON LABSANDA 0713451987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	AEROSOL, FOAM	TOPICAL	OTC	-
5%	AEROSOL, FOAM	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	AEROSOL, FOAM	TOPICAL	OTC	-
5%	AEROSOL, FOAM	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	AEROSOL, FOAM	TOPICAL	OTC	-
5%	AEROSOL, FOAM	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	AEROSOL, FOAM	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	OTC	-
2%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Discontinued	-
2%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	OTC	-
2%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Discontinued	-
2%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Discontinued	-
2%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
2.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

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First approval

Mar 03, 1987

40 yr 3 mo ago

Most recent approval

Jun 30, 2025

1 yr 4 mo ago

Approvals span 1987–2025 across 37 FDA applications.

Brand (NDA) 411%

Generic (ANDA) 3389%

Minoxidil: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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