Viewing data from:

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

4 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	W.D. Pa.	2022-05-20	Active	—
Teva Pharmaceuticals USA, Inc. et al v. Synthon Pharmaceuticals, Inc. et al 1:2017cv00390 6 patentsANDA 206767, 206873, 206921, 206936, 207553Glatiramer Acetate	D. Del.	2017-04-07	Terminated 2017-12-18	—
TEVA PHARMACEUTICALS USA, INC. et al v. Mylan Pharmaceuticals Inc. et al 1:2014cv00167 2 patentsANDA 206936glatiramer acetate	N.D. W. Va.	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).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$95.42

per ml

Lowest NADAC/Unit

$95.42

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00378696112GLATIRAMER 40 MG/ML SYRINGE	$95.42	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$1073.26

Highest Price

$1073.26

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00378-6961-12GLATIRAMER ACETATE 40MG/ML INJ,SYR,1ML	$1073.26	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 active DMFs

6 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

HYBIO PHARMACEUTICAL CO LTDGLATIRAMER ACETATE, NON-STERILE BULK DRUG SUBSTANCE

DMF 289892014

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.