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GLATIRAMER ACETATE

ANDA

GLATIRAMER ACETATE | A206873 | SYNTHON PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: COPAXONE(TE code: AP)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
TEVA PHARMACEUTICALS USA, INC. et al v. SYNTHON PHARMACEUTICALS, INC. et al 1:2014cv00975 2 patentsANDA 206873glatiramer acetate	NCMD	2014-11-19	Terminated 2015-02-12	—
Teva Pharmaceuticals USA Inc. et al v. Synthon Pharmaceuticals, Inc. et al 1:2014cv01419 2 patentsANDA 206873glatiramer acetate	D. Del.	2014-11-18	Terminated 2017-01-31	—

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

API Supply Chain5 active DMFs

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

DR REDDYS LABORATORIES LTDGLATIRAMER ACETATE

DMF 258552012

AMBIO INCGLATIRAMER ACETATE

DMF 264892012

AMNEAL PHARMACEUTICALS LLCGLATIRAMER ACETATE

DMF 277232013

GLAND PHARMA LTDGLATIRAMER ACETATE

DMF 330922018

AURO PEPTIDES LTDGLATIRAMER ACETATE

DMF 354932020

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

Products (1)

#001 — 40MG/ML

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Sep 25, 2024

No patent or exclusivity listings for this strength.