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TAPENTADOL HYDROCHLORIDE

ANDA

TAPENTADOL HYDROCHLORIDE | A205057 | HIKMA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Janssen Pharmaceuticals, Inc. et al v. Roxane Laboratories, Inc. 3:2013cv00639 1 patentANDA 205057tapentadol hydrochloride	D. Nev.	2013-11-15	Terminated 2014-03-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain5 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

NORAMCO LLCTAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE

DMF 210842008

CURIA MISSOURI INCTAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE

DMF 264902012

ALKEM LABORATORIES LTDTAPENTADOL HYDROCHLORIDE

DMF 265192012

ALKEM LABORATORIES LTDTAPENTADOL HYDROCHLORIDE

DMF 314352017

MSN ORGANICS PRIVATE LTDTAPENTADOL HYDROCHLORIDE

DMF 413162025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (3)

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#001 — EQ 50MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 10, 2026

No patent or exclusivity listings for this strength.

#002 — EQ 75MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 10, 2026

#003 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 10, 2026