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DESVENLAFAXINE SUCCINATE

ANDA

DESVENLAFAXINE SUCCINATE | A204003 | ALEMBIC PHARMACEUTICALS LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PRISTIQ(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Zydus Pharmaceuticals USA Inc. et al 1:2012cv00808 2 patentsANDA 204003O-desmethylvenlafaxine succinate	D. Del.	2012-06-22	Terminated 2014-08-06	—

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

API Supply Chain19 active DMFs1 inactive

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

ZYDUS LIFESCIENCES LTDDESVENLAFAXINE SUCCINATE USP

DMF 254472012

WOCKHARDT LTDDESVENLAFAXINE SUCCINATE MONOHYDRATE

DMF 256562012

TAPI NL BVDESVENLAFAXINE SUCCINATE

DMF 257492012

LUPIN MANUFACTURING SOLUTIONS LTDDESVENLAFAXINE SUCCINATE

DMF 257512012

APOTEX INCDESVENLAFAXINE SUCCINATE MONOHYDRATE

DMF 257772012

MSN LIFE SCIENCES PRIVATE LTDDESVENLAFAXINE SUCCINATE MONOHYDRATE USP (FORM-1)

DMF 304372016

MACLEODS PHARMACEUTICALS LTDDESVENLAFAXINE SUCCINATE

DMF 309822017

MSN LIFE SCIENCES PRIVATE LTDDESVENLAFAXINE SUCCINATE MONOHYDRATE USP (FORM-II) [ROUTE CODE "SL"]

DMF 311572016

AURORE LIFE SCIENCES PRIVATE LTDDESVENLAFAXINE SUCCINATE USP

DMF 344292019

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DESVENLAFAXINE SUCCINATE MONOHYDRATE

DMF 370362022

HUBEI HAOSUN PHARMACEUTICAL CO LTDDESVENLAFAXINE SUCCINATE

DMF 372372022

HIKAL LTDDESVENLAFAXINE SUCCINATE USP

DMF 374262022

ATUL BIOSCIENCE LTDDESVENLAFAXINE SUCCINATE USP

DMF 375712022

AMI LIFESCIENCES PRIVATE LTDDESVENLAFAXINE SUCCINATE

DMF 380662023

HETERO DRUGS LTDDESVENLAFAXINE SUCCINATE

DMF 385512023

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDDESVENLAFAXINE SUCCINATE

DMF 386242023

MEGAFINE PHARMA P LTDDESVENLAFAXINE SUCCINATE MONOHYDRATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 408392025

COHANCE LIFESCIENCES LTDDESVENLAFAXINE SUCCINATE

DMF 408462024

SNJ LABS PVT LTDDESVENLAFAXINE SUCCINATE USP

DMF 426392025

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveDESVENLAFAXINE SUCCINATE HPMC PRELIMINARY MIX

DMF 257472012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 8, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 50MG BASE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 29, 2015

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 29, 2015

#003 — EQ 25MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 14, 2018