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DALFAMPRIDINE

ANDA

DALFAMPRIDINE | A206765 | ALKEM LABORATORIES LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: AMPYRA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Acorda Therapeutics Inc. et al v. Alkem Laboratories Ltd. 1:2014cv00917 5 patentsANDA 206765dalfampridine	D. Del.	2014-07-11	Terminated 2016-08-05	—

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.

CU CHEMIE UETIKON GMBHDALFAMPRIDINE

DMF 178602004

JUBILANT PHARMOVA LTDDALFAMPRIDINE USP

DMF 247182011

INDUSTRIALE CHIMICA SRLDALFAMPRIDINE

DMF 276232013

ALKEM LABORATORIES LTDDALFAMPRIDINE USP

DMF 276372013

PROCOS SPADALFAMPRIDINE

DMF 276472013

SUN PHARMACEUTICAL INDUSTRIES LTDDALFAMPRIDINE USP

DMF 276622013

INTAS PHARMACEUTICALS LTDDALFAMPRIDINE

DMF 278192013

APITORIA PHARMA PRIVATE LTDDALFAMPRIDINE

DMF 278432014

MICRO LABS LTDDALFAMPRIDINE USP

DMF 331462018

SHANDONG NEW TIME PHARMACEUTICAL CO LTDDALFAMPRIDINE

DMF 420752025

ENALTEC LABS PRIVATE LTDInactiveDALFAMPRIDINE

DMF 256952012

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

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 30, 2018

No patent or exclusivity listings for this strength.