Zydus Secures USFDA Final Nod for Generic Copaxone, Expanding Access for Multiple Sclerosis Patients

Zydus Lifesciences Limited has announced it has received final approval from the United States Food and Drug Administration (USFDA) for its Glatiramer Acetate Injection, the generic version of Copaxone, in both 20 mg/mL and 40 mg/mL single-dose prefilled syringes. This approval marks a significant step in the availability of affordable treatment options for patients with relapsing forms of Multiple Sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

The newly approved product is classified as an AP-rated substitutable generic, making it a direct and approved alternative to the branded Copaxone. Copaxone has been a mainstay therapy for MS, with annual US sales reaching $719 million as of March 2025, according to IQVIA data.

Zydus developed the Glatiramer Acetate Injection in collaboration with Chemi S.p.A., and the product will be manufactured entirely in Europe. Company leadership highlighted the approval as a demonstration of Zydus’ expertise in developing complex, differentiated generics and its ongoing commitment to expanding access to high-quality, cost-effective healthcare solutions.

This milestone brings Zydus’ total number of final ANDA (Abbreviated New Drug Application) approvals to 426, out of 492 filings since the company began its regulatory journey in 2003-04. The approval further reinforces Zydus’ position as a leader in the generics sector and its dedication to providing comprehensive therapeutic choices for patients worldwide.

Key highlights:

USFDA final approval for Glatiramer Acetate Injection, generic of Copaxone, in 20 mg/mL and 40 mg/mL strengths

Approved for all relapsing forms of Multiple Sclerosis in adults

AP-rated, fully substitutable with the branded product

Developed with Chemi S.p.A., manufactured in Europe

Copaxone’s US sales stood at $719 million as of March 2025

Zydus now holds 426 final ANDA approvals

Sources: Business Wire, Yahoo Finance, Business Upturn