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MEN'S ROGAINE

NDA

MINOXIDIL | N021812 | KENVUE BRANDS LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs3 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

TRIFARMA SPAMINOXIDIL USP

DMF 59771985

OLON SPAMINOXIDIL

DMF 66931986

FLAMMA SPAMINOXIDIL

DMF 159182002

ICROM SRLMINOXIDIL

DMF 172702004

KUMAR ORGANIC PRODUCTS LTDMINOXIDIL USP

DMF 223672009

GLOBAL CALCIUM PRIVATE LTDMINOXIDIL USP

DMF 349392020

SYMBIO GENERRICS INDIA PRIVATE LTDMINOXIDIL USP

DMF 405392025

SMS LIFESCIENCES INDIA LTDMINOXIDIL USP

DMF 411782025

NEW HORIZON PHARMA US INCMINOXIDIL USP

DMF 418132025

ORION CORP LTDInactiveMINOXIDIL

DMF 64661986

GUANGZHOU ZHUJIANG MEDICINE CO INCInactiveMINOXIDIL

DMF 79531989

JICHENG PHARMACEUTICAL FACTORYInactiveMINOXIDIL

DMF 108251994

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jan 15, 2026	SUPPL -20	View Letter (PDF)
Apr 26, 2021	SUPPL -16	View Letter (PDF)
Feb 4, 2020	SUPPL -15	View Letter (PDF)
Jun 12, 2019	SUPPL -14	View Letter (PDF)
Feb 12, 2015	SUPPL -11	View Letter (PDF)
Mar 4, 2014	SUPPL -9	View Letter (PDF)
Dec 17, 2013	SUPPL -10	View Letter (PDF)
May 24, 2006	SUPPL -1	View Letter (PDF)
Jan 30, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5%

RLD

0 patents0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: Jan 20, 2006

No patent or exclusivity listings for this strength.

#002 — 5%

RLD

0 patents0 exclusivities▾

AEROSOL, FOAM;TOPICAL | Approved: Feb 28, 2014