Viewing data from:

ACLOVATE

NDA

ALCLOMETASONE DIPROPIONATE | N018707 | FOUGERA PHARMACEUTICALS INC

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

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Kirkpatrick & Lockhart Nicholson Graham LLP FDA-2006-P-0514 · 4 docket documents The document provided contains Orange Book search results for Aclovate (alclometasone dipropionate) cream and ointment 0.05% topical formulations approved to GlaxoSmithKline under application number 018707, showing no unexpired patents or exclusivity. However, the document does not contain the actua	Other	2009-02-11	Withdrawn	Kirkpatrick & Lockhart Nicholson Graham LLP

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

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO NCT01465802	Phase 2	Completed	Pfizer	236	2011-12-26 → 2015-05-18
Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream NCT02075632	Phase 2	Completed	GlaxoSmithKline	310	2006-09 → 2006-11

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

API Supply Chain3 active DMFs1 inactive

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

TAPI NL BVALCLOMETASONE DIPROPIONATE

DMF 146922000

CURIA SPAIN SAUALCLOMETASONE DIPROPIONATE

DMF 168712003

NEWCHEM SPAALCLOMETASONE DIPROPIONATE MICRONIZED

DMF 433552026

SCHERING PHARMACEUTICAL CORPInactiveALCLOMETASONE DIPROPIONATE, USP

DMF 89441991

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 11, 2011	SUPPL -12	View Letter (PDF)
Apr 16, 2003	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 14, 1982

No patent or exclusivity listings for this strength.