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LEVOMILNACIPRAN HYDROCHLORIDE

ANDA

LEVOMILNACIPRAN HYDROCHLORIDE | A210771 | PRINSTON PHARMACEUTICAL INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FETZIMA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED et al v. PRINSTON PHARMACEUTICAL INC. et al 2:2017cv10230 3 patentsANDA 210771levomilnacipran	D.N.J.	2017-10-31	Terminated 2021-09-14	—

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

API Supply Chain10 active DMFs1 inactive

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

PIERRE FABRE MEDICAMENTLEVOMILNACIPRAN

DMF 223512008

RAKS PHARMA PVT LTDLEVOMILNACIPRAN HYDROCHLORIDE

DMF 280152014

MICRO LABS LTDLEVOMILNACIPRAN HYDROCHLORIDE

DMF 297332015

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLEVOMILNACIPRAN HYDROCHLORIDE

DMF 297742015

MSN LIFE SCIENCES PRIVATE LTDLEVOMILNACIPRAN HYDROCHLORIDE

DMF 308912016

ZYDUS LIFESCIENCES LTDLEVOMILNACIPRAN HYDROCHLORIDE

DMF 312232016

COSMA SPALEVOMILNACIPRAN HYDROCHLORIDE

DMF 313272017

QUIMICA SINTETICA SALEVOMILNACIPRAN HYDROCHLORIDE

DMF 313472017

CENTAUR PHARMACEUTICALS PRIVATE LTDLEVOMILNACIPRAN HYDROCHLORIDE

DMF 316992017

HETERO LABS LTDLEVOMILNACIPRAN HYDROCHLORIDE

DMF 330952018

MSN PHARMACHEM PRIVATE LTDInactiveLEVOMILNACIPRAN HYDROCHLORIDE [ROUTE CODE - "LM"]

DMF 280162014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 7, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — EQ 20MG BASE

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 20, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 20, 2023

#003 — EQ 80MG BASE

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 20, 2023

#004 — EQ 120MG BASE

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 20, 2023