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OPANA

NDA

OXYMORPHONE HYDROCHLORIDE | N021611 | ENDO PHARMACEUTICALS 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs4 inactive

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

SPECGX LLCOXYMORPHONE HYDROCHLORIDE USP

DMF 145021999

NORAMCO LLCOXYMORPHONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 228162009

DIOSYNTH INCInactiveOXYMORPHONE HYDROCHLORIDE

DMF 74511988

MALLINCKRODT CHEMICAL INCInactiveOXYMORPHONE HYDROCHLORIDE

DMF 91091991

SIEGFRIED USA INCInactiveOXYMORPHONE HYDROCHLORIDE USP

DMF 234032009

SIEGFRIED USA LLCInactiveOXYMORPHONE HYDROCHLORIDE USP (LOW ABUK IMPURITY)

DMF 256282011

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

Approval Letters

10 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

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#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 22, 2006

No patent or exclusivity listings for this strength.

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 22, 2006