Orange Book product · Brand (NDA)

OPANA ER

OXYMORPHONE HYDROCHLORIDE

Brand (NDA)NDA 201655DISCN ENDO PHARMS

Dec 09, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 09, 2011
14 yr 9 mo ago
Today
Patent 8808737 expires
Listed method-of-use patent (U-1598) expiration.
Jun 21, 2027
in 1 yr
Patent 7851482 expires
Listed drug substance patent expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 8871779 expires
Listed drug substance patent expiration.
Nov 22, 2029
in 3 yr 6 mo

Active ingredient

OXYMORPHONE HYDROCHLORIDE

Strength

5MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 201655

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-1598
7851482	Jul 10, 2029	in 3 yr 1 mo	Substance
8871779	Nov 22, 2029	in 3 yr 6 mo	Substance