Orange Book product · Brand (NDA)

NUCYNTA ER

TAPENTADOL HYDROCHLORIDE

Brand (NDA)NDA 200533RX COLLEGIUM PHARM INC

Aug 25, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 25, 2011
15 yr ago
Today
Patent 11344512 expires
Listed method-of-use patent (U-3391) expiration.
Apr 21, 2028
in 1 yr 10 mo
Patent 11344512 expires
Listed method-of-use patent (U-3392) expiration.
Apr 21, 2028
in 1 yr 10 mo
Patent 8536130 expires
Listed method-of-use patent (U-1276) expiration.
Sep 22, 2028
in 2 yr 4 mo
Patent 11344512*PED expires
Listed listed patent expiration.
Oct 21, 2028
in 2 yr 5 mo
Patent 8536130*PED expires
Listed listed patent expiration.
Mar 22, 2029
in 2 yr 10 mo

Active ingredient

TAPENTADOL HYDROCHLORIDE

Strength

EQ 50MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 200533

Product number

001

Marketing status

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
11344512	Apr 21, 2028	in 1 yr 10 mo	U-3391
11344512	Apr 21, 2028	in 1 yr 10 mo	U-3392
8536130	Sep 22, 2028	in 2 yr 4 mo	U-1276
11344512*PED	Oct 21, 2028	in 2 yr 5 mo
8536130*PED	Mar 22, 2029	in 2 yr 10 mo