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LONITEN

NDA

MINOXIDIL | N018154 | PFIZER INC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Baker & Hostetler LLP - Citizen Petition FDA-2008-P-0643 · 5 docket documents Baker & Hostetler LLP, on behalf of its client, submitted this ANDA suitability petition under Section 505(j)(2)(C) requesting that FDA declare a new topical dosage form of minoxidil suitable for abbreviated new drug application consideration. The petitioner seeks to change the dosage form from a to	Other	2008-12-22	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

37 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 25 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia NCT03831334	Early Phase 1	Active	Northwestern University	14	2019-04-09 → 2026-08
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study NCT04207931	Phase 4	Recruiting	Wake Forest University Health Sciences	250	2018-04-30 → 2027-03
Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss NCT01325350	Phase 2	Completed	Allergan	306	2011-06 → 2012-09
Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women NCT03488108	Phase 1/2	Completed	Mayo Clinic	20	2017-01-23 → 2019-06-17
Efficacy of Minoxidil in Children With Williams-Beuren Syndrome NCT00876200	Phase 2	Completed	Hospices Civils de Lyon	21	2009-03 → 2015-08
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss NCT00151515	Phase 3	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	352	2003-10 → 2004-07
Microarray Analysis of Scalp Biopsies After Minoxidil Treatment NCT01309191	N/A	Completed	University Hospitals Cleveland Medical Center	14	2011-04 → 2012-04
Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss NCT00175617	Phase 2	Completed	University of British Columbia	40	2005-09 → 2009-03-09
Minoxidil 2% for Eyebrow Enhancement NCT01672307	Phase 4	Completed	Mae Fah Luang University Hospital	40	2012-09 → 2013-03
Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application NCT02280603	Phase 1/2	Completed	Dong-A ST Co., Ltd.	60	2014-01 → 2014-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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

2 letters from Drugs@FDA

Date	Submission	Document
Jan 15, 2015	SUPPL -26	View Letter (PDF)
Jul 9, 2002	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982