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DARVON

NDA

PROPOXYPHENE HYDROCHLORIDE | N010997 | XANODYNE PHARMACEUTICS 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Barbara L. Maw, P.C. - Citizen Petition FDA-2011-P-0064 Barbara L. Maw, an attorney representing John and Jane Does 1-500, filed this citizen petition on January 20, 2011, requesting that the FDA vacate and revoke its voluntary recall of propoxyphene-containing products including Darvon and Darvocet pursuant to 21 U.S.C. Section 355(f) and 21 C.F.R. 10.3	Other	2011-01-31	Denied	—
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0145 Lachman Consultant Services, Inc. filed this citizen petition on December 12, 2006, pursuant to Section 505(q)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare a Propoxyphene Hydrochloride 65 mg and Acetaminophen 325 mg tablet suitable for submission as an ANDA, with	Other	2008-11-17	Granted	Lachman Consultant Services, Inc.

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

Clinical Trials

2 trials from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
Lumbar Stenosis Outcomes Research II NCT00652093	Phase 4	Terminated	University of Rochester	24	2008-03 → 2011-08
Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects NCT01133873	Phase 4	Terminated	Xanodyne Pharmaceuticals	48	2010-06 → 2010-11

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

API Supply Chain0 active DMFs6 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

DINAMITE DIPHARMA SPAInactivePROPOXYPHENE HYDROCHLORIDE

DMF 13501969

GYMA LABORATORIES AMERICA INCInactivePROPOXYPHENE HYDROCHLORIDE

DMF 18221971

SIEGFRIED USA INCInactivePROPOXYPHENE HYDROCHLORIDE

DMF 27771976

MALLINCKRODT CHEMICAL INCInactivePROPOXYPHENE HYDROCHLORIDE

DMF 61551985

MALLINCKRODT INC THE PHARMACEUTICALS BUSINESS OF COVIDIENInactivePROPOXYPHENE HYDROCHLORIDE USP POWDER (E SUB)

DMF 140041999

CAMBREX CHARLES CITY INCInactivePROPOXYPHENE HYDROCHLORIDE

DMF 175022004

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 32MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — 65MG

0 patents0 exclusivities▾

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