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 Pharma Intl, Aurobindo Pharma, 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, Endo Operations, Royce Labs, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for minoxidil. One hundred and five suppliers are listed for this compound.

Summary for MINOXIDIL

US Patents:	0
Tradenames:	12
Applicants:	24
NDAs:	35
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	105
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	62
Patent Applications:	6,717
Drug Prices:	Drug price trends for MINOXIDIL
What excipients (inactive ingredients) are in MINOXIDIL?	MINOXIDIL excipients list
DailyMed Link:	MINOXIDIL at DailyMed

See drug prices for MINOXIDIL

Recent Clinical Trials for MINOXIDIL

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

Sponsor	Phase
Industrial Farmacéutica Cantabria, S.A.	Phase 1
Bioskin GmbH	Phase 3
BioClever 2005 S.L.	Phase 3

See all MINOXIDIL clinical trials

Pharmacology for MINOXIDIL

Drug Class	Arteriolar Vasodilator
Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for MINOXIDIL

Antihypertensive Agents
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for MINOXIDIL

C02DC	Pyrimidine derivatives
C02D	ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	MINOXIDIL (FOR MEN)	minoxidil	SOLUTION;TOPICAL	074924-001	Apr 29, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	MINOXIDIL	minoxidil	TABLET;ORAL	072709-001	Dec 14, 1995	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	MINOXIDIL	minoxidil	TABLET;ORAL	072709-002	Dec 14, 1995	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Johnson And Johnson	WOMEN'S ROGAINE	minoxidil	AEROSOL, FOAM;TOPICAL	021812-002	Feb 28, 2014		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Usl Pharma	MINOXIDIL	minoxidil	TABLET;ORAL	071537-001	Dec 16, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	MINOXIDIL (FOR WOMEN)	minoxidil	AEROSOL, FOAM;TOPICAL	218616-002	Apr 22, 2024		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	MINOXIDIL (FOR WOMEN)	minoxidil	AEROSOL, FOAM;TOPICAL	209074-002	Apr 22, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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	⤷ Sign Up	⤷ Sign Up
Pfizer	LONITEN	minoxidil	TABLET;ORAL	018154-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Pfizer	LONITEN	minoxidil	TABLET;ORAL	018154-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Johnson And Johnson	WOMEN'S ROGAINE	minoxidil	AEROSOL, FOAM;TOPICAL	021812-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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