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ALDARA

NDA

IMIQUIMOD | N020723 | BAUSCH HEALTH US LLC

1 strength0 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
GRACEWAY PHARMACEUTICALS, LLC et al v. PERRIGO COMPANY et al 2:2010cv00937 2 patentsANDA 78837, 78548imiquimod	D.N.J.	2010-02-23	Terminated 2016-07-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients NCT07679841	Phase 1/2	Not Yet Recruiting	Centre Leon Berard	50	2026-09 → 2029-09

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

API Supply Chain10 active DMFs3 inactive

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

TARO PHARMACEUTICAL INDUSTRIES LTDIMIQUIMOD USP

DMF 180312005

TAPI NL BVIMIQUIMOD

DMF 187822005

WAVELENGTH ENTERPRISES LTDIMIQUIMOD

DMF 190092005

TEVA PHARMACEUTICAL INDUSTRIES LTDIMIQUIMOD

DMF 195072006

ALIVUS LIFE SCIENCES LTDIMIQUIMOD USP

DMF 197352006

INTERQUIM SAIMIQUIMOD

DMF 202472007

USV PRIVATE LTDIMIQUIMOD USP

DMF 203532007

ACTAVIS GROUP PTC EHFIMIQUIMOD USP [NON-STERILE DRUG SUBSTANCE]

DMF 216102008

SOLARA ACTIVE PHARMA SCIENCES LTDIMIQUIMOD

DMF 221592008

WANBURY LTDIMIQUIMOD

DMF 320172017

TAI HENG INDUSTRY CO LTDInactiveIMIQUIMOD

DMF 202562007

AMINO CHEMICALS LTDInactiveIMIQUIMOD

DMF 207362007

CIPLA LTDInactiveIMIQUIMOD

DMF 219272008

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Sep 26, 2024	SUPPL -28	View Letter (PDF)
Oct 19, 2010	SUPPL -22	View Letter (PDF)
Mar 31, 2007	SUPPL -20	View Letter (PDF)
Aug 11, 2005	SUPPL -18	View Letter (PDF)
Jul 21, 2004	SUPPL -16	View Letter (PDF)
May 26, 2004	SUPPL -11	View Letter (PDF)
May 26, 2004	SUPPL -10	View Letter (PDF)
May 26, 2004	SUPPL -12	View Letter (PDF)
Mar 3, 2004	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Feb 27, 1997

No patent or exclusivity listings for this strength.