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GLATIRAMER ACETATE

ANDA

GLATIRAMER ACETATE | A208468 | CHEMI SPA

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: COPAXONE(TE code: AP)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$91.07

per ml

Lowest NADAC/Unit

$42.68

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70710154906GLATIRAMER 40 MG/ML SYRINGE	$91.07	ML	Generic	—	2026-08-19
70710154809GLATIRAMER 20 MG/ML SYRINGE	$42.68	ML	Generic	—	2026-08-19

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

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.

Products (2)

Sort:

#001 — 20MG/ML

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: May 7, 2025

No patent or exclusivity listings for this strength.

#002 — 40MG/ML

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: May 7, 2025