Orange Book product · Brand (NDA)

XARTEMIS XR

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Brand (NDA)NDA 204031DISCN MALLINCKRODT INC

Mar 11, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 11, 2014
12 yr 5 mo ago
Today
Patent 7976870 expires
Listed method-of-use patent (U-1498) expiration.
Jun 01, 2027
in 1 yr
Patent 8372432 expires
Listed drug product patent expiration.
Mar 11, 2029
in 2 yr 9 mo
Patent 8394408 expires
Listed drug product patent expiration.
Mar 11, 2029
in 2 yr 9 mo
Patent 8668929 expires
Listed method-of-use patent (U-1499) expiration.
Mar 11, 2029
in 2 yr 9 mo
Patent 8377453 expires
Listed drug product patent expiration.
Nov 19, 2029
in 3 yr 6 mo
Patent 8597681 expires
Listed drug product patent expiration.
Dec 21, 2030
in 4 yr 7 mo
Patent 8980319 expires
Listed drug product patent expiration.
Dec 21, 2030
in 4 yr 7 mo
Patent 8658631 expires
Listed drug product patent expiration.
May 16, 2032
in 6 yr
Patent 8741885 expires
Listed drug product patent expiration.
May 16, 2032
in 6 yr
Patent 8992975 expires
Listed drug product patent expiration.
May 16, 2032
in 6 yr
Patent 9050335 expires
Listed drug product patent expiration.
May 16, 2032
in 6 yr
Patent 9468636 expires
Listed method-of-use patent (U-1499) expiration.
May 16, 2032
in 6 yr

Active ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Strength

325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 204031

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
7976870	Jun 01, 2027	in 1 yr	U-1498
8372432	Mar 11, 2029	in 2 yr 9 mo	ProductU-1499
8394408	Mar 11, 2029	in 2 yr 9 mo	Product
8668929	Mar 11, 2029	in 2 yr 9 mo	U-1499
8377453	Nov 19, 2029	in 3 yr 6 mo	ProductU-1499
8597681	Dec 21, 2030	in 4 yr 7 mo	Product
8980319	Dec 21, 2030	in 4 yr 7 mo	Product
8658631	May 16, 2032	in 6 yr	Product
8741885	May 16, 2032	in 6 yr	ProductU-1499
8992975	May 16, 2032	in 6 yr	Product
9050335	May 16, 2032	in 6 yr	Product
9468636	May 16, 2032	in 6 yr	U-1499