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OXYMORPHONE HYDROCHLORIDE

ANDA

OXYMORPHONE HYDROCHLORIDE | A203506 | SUN PHARMACEUTICAL INDUSTRIES LTD

7 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Endo Pharmaceuticals Inc. et al v Sun Pharmaceutical Laboratories Ltd. et al 1:2014cv01386 2 patentsANDA 203506, 204527oxymorphone hydrochloride	D. Del.	2014-11-07	Terminated 2018-09-04	—

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Apr 28, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.