Minoxidil

Sold as Loniten, Rogaine, Rogaine Extra Strength, Men'S Rogaine, Women'S Rogaine. Every FDA application for this active ingredient: 4 branded and 33 generic.

As of Nov 14, 2026, FDA lists 37 applications for Minoxidil (sold as Loniten, Rogaine, Rogaine Extra Strength and others), first approved Oct 18, 1979, with 3 new uses approved and 0 published complete response letters.

First approved: Oct 18, 1979
Applications: 37
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $12.4M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Minoxidil	Part D	$12.4M	+41%	255,607

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

MINOXIDIL 10 MG TABLET: $0.151 per unitGeneric · -26% in a year
MINOXIDIL 2.5 MG TABLET: $0.097 per unitGeneric · 0% in a year

Clinical Trials

31 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Evaluation of the Scalp Skin Care Effects of Premium Revitalizing Elixir and Topical 5% MinoxidilScalp Health, Alopecia · Hungkuang University	Not applicable	Active, not recruiting	Oct 28, 2026
Oral Minoxidil With or Without a Multifactorial Drinkable Nutraceutical in Female Pattern Hair Loss: a Retrospective StudyFemale Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia · Olistic Research Labs S.L.	—	Not yet recruiting	Oct 7, 2026
Effects of a Topical Serum Solution on Hair CharacteristicsHair Characteristics · Pacagen, Inc.	Not applicable	Active, not recruiting	Aug 25, 2026
A Study on the Efficacy and Safety of Microneedling for Male Androgenetic AlopeciaAndrogenetic Alopecia · Cheng Zhou	Not applicable	Not yet recruiting	Aug 11, 2026
For an Investigator-led Hair Study Comparing Between Healthy and Hair Loss VolunteersHair Loss · National Skin Centre	—	Not yet recruiting	Jul 21, 2026
Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer PatientsAnatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8 · Ohio State University Comprehensive Cancer Center	Phase 2	Not yet recruiting	May 19, 2026
JAK2 Expression in Androgenetic Alopecia Before and After Topical MinoxidilAndrogenetic Alopecia, Androgenic Alopecia · Kasr El Aini Hospital	Not applicable	Recruiting	May 1, 2026
Comparative Study of Microneedling With Topical Minoxidil 5% ± NB-UVB in Stable Vitiligo"Vitiligo - Macular Depigmentation · Sohag University	Phase 2	Not yet recruiting	Apr 23, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 18, 1979	LonitenNDA 18154 · New molecular entity	Pfizer	20	Discontinued
Mar 3, 1987	MinoxidilANDA 71345	Watson Labs	17	Marketed
Mar 3, 1987	MinoxidilANDA 71344	Watson Labs	16	Marketed
Aug 17, 1988	RogaineNDA 19501 · New dosage form	Kenvue Brands	21	Marketed
Nov 14, 1988	MinoxidilANDA 71839	Ph Health	7	Marketed
Nov 14, 1988	MinoxidilANDA 71826	Ph Health	7	Marketed
Dec 13, 1995	MinoxidilANDA 72709	Sun Pharm Industries	8	Marketed
Apr 5, 1996	MinoxidilANDA 74588	P And L	14	Marketed
Apr 5, 1996	MinoxidilANDA 74589	Teva	6	Discontinued
Apr 9, 1996	MinoxidilANDA 74643	Bausch And Lomb	8	Discontinued
May 23, 1996	MinoxidilANDA 74500	Copley Pharm	5	Discontinued
Oct 18, 1996	MinoxidilANDA 74743	Sight Pharms	2	Discontinued
Dec 24, 1996	MinoxidilANDA 74731	Hikma	2	Discontinued
Feb 28, 1997	MinoxidilANDA 74767	Aurobindo Pharma Ltd	2	Marketed
Nov 14, 1997	Rogaine Extra StrengthNDA 20834 · New dosage form	Kenvue Brands	7	Marketed
Apr 29, 1998	MinoxidilANDA 74924	Apotex Inc	9	Discontinued
Jul 30, 1999	MinoxidilANDA 75357	L Perrigo Co	3	Marketed
Nov 17, 2000	Minoxidil Extra StrengthANDA 75518	P And L	8	Marketed
Nov 17, 2000	Minoxidil Extra StrengthANDA 75619	Avacor Prods	1	Discontinued
Jun 13, 2001	Minoxidil Extra StrengthANDA 75598	Perrigo	4	Marketed
Oct 1, 2001	Minoxidil Extra StrengthANDA 75839	Apotex Inc	6	Discontinued
Mar 15, 2002	Minoxidil Extra StrengthANDA 75737	Perrigo New York	0	Discontinued
Feb 27, 2003	Minoxidil Extra StrengthANDA 75438	Aurobindo Pharma Ltd	0	Marketed
Aug 24, 2004	TheroxidilANDA 76239	Pure Source	2	Marketed
Jan 20, 2006	Men'S Rogaine, Women'S RogaineNDA 21812 · New dosage form	Kenvue Brands	9	Marketed
Nov 9, 2007	TheroxidilANDA 78176	Pure Source	1	Marketed
Apr 28, 2011	MinoxidilANDA 91344	Perrigo Pharma Intl	3	Marketed
Jul 27, 2017	MinoxidilANDA 208092	P And L	0	Marketed
Apr 22, 2019	MinoxidilANDA 209074	Taro	4	Marketed
Apr 22, 2024	MinoxidilANDA 218616	Aurobindo Pharma	0	Marketed
Nov 26, 2024	MinoxidilANDA 218175	Taro	0	Marketed
Jun 30, 2025	Minoxidil Extra StrengthANDA 217998	Taro	0	Marketed
—	MinodylANDA 72153	Quantum Pharmics	0	Discontinued
—	MinodylANDA 71534	Quantum Pharmics	3	Discontinued
—	MinoxidilANDA 71537	Usl Pharma	0	Discontinued
—	MinoxidilANDA 71796	Royce Labs	0	Discontinued
—	MinoxidilANDA 71799	Royce Labs	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA