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DARVON-N

NDA

PROPOXYPHENE NAPSYLATE | N016862 | XANODYNE PHARMACEUTICS 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc FDA-2006-P-0280 · 7 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Propoxyphene Napsylate 100 mg and Acetaminophen 400 mg Tablet suitable for submission as an ANDA, seeking approval for a reduced acetaminophen strength compared to the reference-listed drug Da	Other	2008-11-19	Granted	Lachman Consultant Services, Inc
Lachman Consultant Services, Inc. - CP1 FDA-2006-P-0456 · 8 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Propoxyphene Napsylate 100 mg with Acetaminophen 300 mg Tablets and Propoxyphene Napsylate 50 mg with Acetaminophe	Other	2008-07-14	Granted	—

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

Clinical Trials

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
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.

SIEGFRIED AGInactivePROPOXYPHENE NAPSYLATE

DMF 35111979

SIEGFRIED USA INCInactivePROPOXYPHENE NAPSYLATE, BULK FORM

DMF 35581979

AAI PHARMA LLCInactivePROPOXYPHENE NAPSYLATE

DMF 48801983

AAI PHARMA LLCInactivePROPOXYPHENE NAPSYLATE PRODUCED BY TIPPECANOE LABS IN LAFAYETTE, IN.

DMF 54771984

MALLINCKRODT CHEMICAL INCInactivePROPOXYPHENE NAPSYLATE

DMF 61361985

CAMBREX CHARLES CITY INCInactivePROPOXYPHENE NAPSYLATE

DMF 175032004

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 (1)

#002 — 100MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.