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ELIGLUSTAT TARTRATE

ANDA

ELIGLUSTAT TARTRATE | A212474 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Genzyme Corp. et al v. Teva Pharmaceuticals USA, Inc. 1:2018cv01796 4 patentsANDA 212474Eliglustat	D. Del.	2018-11-14	Terminated 2020-08-03	—

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

API Supply Chain7 active DMFs

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

DR REDDYS LABORATORIES LTDELIGLUSTAT TARTRATE

DMF 314752017

BIOPHORE INDIA PHARMACEUTICALS PVT LTDELIGLUSTAT TARTRATE

DMF 325722018

MAITHRI LABORATORIES PRIVATE LTDELIGLUSTAT TARTRATE (PREMIX)

DMF 326122018

MAITHRI LABORATORIES PRIVATE LTDELIGLUSTAT TARTRATE

DMF 326532018

APOTEX INCELIGLUSTAT TARTRATE (1:0.5)

DMF 327242018

BIOPHORE INDIA PHARMACEUTICALS PVT LTDELIGLUSTAT TARTRATE PREMIX

DMF 328602018

HETERO DRUGS LTDELIGLUSTAT TARTRATE

DMF 416192025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 24, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 84MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 27, 2021

No patent or exclusivity listings for this strength.