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DOXEPIN HYDROCHLORIDE

ANDA

DOXEPIN HYDROCHLORIDE | A202337 | RK PHARMA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SILENOR(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Somaxon Pharmaceuticals Inc. et al v. Actavis Elizabeth LLC et al 1:2010cv01100 1 patentANDA 201951, 202337doxepin hydrochloride	D. Del.	2010-12-15	Terminated 2022-10-03	—

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

API Supply Chain4 active DMFs2 inactive

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

OLON SPADOXEPIN HYDROCHLORIDE

DMF 50251983

MSN LIFE SCIENCES PRIVATE LTDDOXEPIN HYDROCHLORIDE USP

DMF 335592019

R L FINE CHEM PVT LTDDOXEPIN HYDROCHLORIDE

DMF 344382020

RAKS PHARMA PVT LTDDOXEPIN HYDROCHLORIDE USP

DMF 350172020

BOEHRINGER MANNHEIM GMBHInactiveDOXEPIN

DMF 24101975

GANES CHEMICALS INC PENNSVILLE DIVInactiveDOXEPIN HYDROCHLORIDE

DMF 68561987

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

Products (2)

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#001 — EQ 3MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 20, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 6MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 20, 2016