Orange Book product · Brand (NDA)

NUCYNTA

TAPENTADOL HYDROCHLORIDE

Brand (NDA)NDA 022304TE ABRX COLLEGIUM PHARM INC

View TAPENTADOL HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Nov 20, 2008

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Nov 20, 2008
17 yr 10 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Jul 03, 2026
in 14 d
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jan 03, 2027
in 7 mo

Pharmaceutical detail

Active ingredient

TAPENTADOL HYDROCHLORIDE

Strength

EQ 50MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 022304

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

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

Marketing exclusivity (2)

NPPNew patient population exclusivity (3 years)
Jul 03, 2026
in 14 d
PEDPediatric exclusivity (adds 6 months)
Jan 03, 2027
in 7 mo

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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