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SAFINAMIDE MESYLATE

ANDA

SAFINAMIDE MESYLATE | A215913 | ZENARA PHARMA PRIVATE LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: XADAGO(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Newron Pharmaceuticals S.p.A et al v. MSN Laboratories Private Limited et al 1:2021cv00843 3 patentsANDA 215902, 215978, 216020, 215739, 215945, 215913safinamide	D. Del.	2021-06-10	Terminated 2023-11-22	—

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

API Supply Chain10 active DMFs

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

FIS FABBRICA ITALIANA SINTETICI SPASAFINAMIDE

DMF 322252018

MSN LIFE SCIENCES PRIVATE LTDSAFINAMIDE MESYLATE

DMF 337252019

APICORE PHARMACEUTICALS PRIVATE LTDSAFINAMIDE MESYLATE

DMF 343992020

MSN LIFE SCIENCES PRIVATE LTDSAFINAMIDE MESYLATE (PROCESS-2)

DMF 346282020

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDSAFINAMIDE MESYLATE

DMF 350962020

OPTIMUS DRUGS PRIVATE LTDSAFINAMIDE MESYLATE

DMF 351382020

APITORIA PHARMA PRIVATE LTDSAFINAMIDE MESYLATE

DMF 351792020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSAFINAMIDE MESYLATE

DMF 352012020

SOLARA ACTIVE PHARMA SCIENCES LTDSAFINAMIDE MESYLATE

DMF 357192021

HOSTER LABS PRIVATE LTDSAFINAMIDE MESYLATE

DMF 401102024

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

Products (2)

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#001 — EQ 50MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 13, 2025

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 13, 2025