Orange Book product · Brand (NDA)

RELISTOR

METHYLNALTREXONE BROMIDE

Brand (NDA)NDA 208271RX SALIX

Jul 19, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 19, 2016
10 yr 1 mo ago
Today
Patent 8420663 expires
Listed method-of-use patent (U-1185) expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9180125 expires
Listed drug product patent expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9492445 expires
Listed drug product patent expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9724343 expires
Listed drug product patent expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 10307417 expires
Listed drug product patent expiration.
Mar 10, 2031
in 4 yr 10 mo
Patent 10376505 expires
Listed drug product patent expiration.
Mar 10, 2031
in 4 yr 10 mo
Patent 8524276 expires
Listed drug product patent expiration.
Mar 10, 2031
in 4 yr 10 mo
Patent 8956651 expires
Listed drug product patent expiration.
Mar 10, 2031
in 4 yr 10 mo
Patent 9314461 expires
Listed drug product patent expiration.
Mar 10, 2031
in 4 yr 10 mo

Active ingredient

METHYLNALTREXONE BROMIDE

Strength

150MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 208271

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
8420663	Sep 30, 2029	in 3 yr 4 mo	U-1185
9180125	Sep 30, 2029	in 3 yr 4 mo	ProductU-1185
9492445	Sep 30, 2029	in 3 yr 4 mo	ProductU-1185
9724343	Sep 30, 2029	in 3 yr 4 mo	ProductU-1185
10307417	Mar 10, 2031	in 4 yr 10 mo	Product
10376505	Mar 10, 2031	in 4 yr 10 mo	Product
8524276	Mar 10, 2031	in 4 yr 10 mo	Product
8956651	Mar 10, 2031	in 4 yr 10 mo	Product
9314461	Mar 10, 2031	in 4 yr 10 mo	Product