Viewing data from:

GLATIRAMER ACETATE

ANDA

GLATIRAMER ACETATE | A091646 | MYLAN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: COPAXONE(TE code: AP)

Hatch-Waxman Litigation

1 case 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	—

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

Medicare Part D Spending

CMS annual spending data for Glatiramer Acetate (2023)

Total Spending

$151.5M

Total Claims

43,239

Beneficiaries

5,660

Avg Cost/Unit

$270.93

Spending Trend

$232.0M(2019)→$212.4M(2020)→$178.7M(2021)→$160.1M(2022)→$151.5M(2023)

YoY Change:-4.3%

5yr CAGR:-1.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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 5, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/ML

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Oct 3, 2017

No patent or exclusivity listings for this strength.