Orange Book product · Brand (NDA)

OPANA ER

OXYMORPHONE HYDROCHLORIDE

Brand (NDA)NDA 021610DISCN ENDO OPERATIONS

Jun 22, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 22, 2006
20 yr 3 mo ago
Today
Patent 8808737 expires
Listed method-of-use patent (U-3085) expiration.
Jun 21, 2027
in 1 yr
Patent 8871779 expires
Listed drug substance patent expiration.
Nov 22, 2029
in 3 yr 6 mo

Active ingredient

OXYMORPHONE HYDROCHLORIDE

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 021610

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8808737	Jun 21, 2027	in 1 yr	U-3085
8871779	Nov 22, 2029	in 3 yr 6 mo	Substance