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GLATIRAMER ACETATE

ANDA

GLATIRAMER ACETATE | A206936 | MYLAN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: COPAXONE(TE code: AP)

Hatch-Waxman Litigation

3 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
MOMENTA PHARMACEUTICALS, INC. v. MYLAN PHARMACEUTICALS, INC. et al 2:2022cv00750 2 patentsANDA 090218, 206921, 091646, 206936glatiramer acetate	PAWD	2022-05-20	Active	—
TEVA PHARMACEUTICALS USA, INC. et al v. Mylan Pharmaceuticals Inc. et al 1:2014cv00167 2 patentsANDA 206936glatiramer acetate	WVND	2014-10-07	Terminated 2017-06-27	—
Teva Pharmaceuticals USA Inc. et al v. Mylan Pharmaceuticals Inc. et al 1:2014cv01278 2 patentsANDA 206936glatiramer acetate	D. Del.	2014-10-06	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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 6, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Oct 3, 2017

No patent or exclusivity listings for this strength.