Zydus Lifesciences Limited has informed the Exchange regarding a press release dated May 08, 2025, titled "Zydus receives final approval from USFDA for Glatiramer Acetate Injection, the generic version of Copaxone? 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes".
ZYDUSLIFE · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
Zydus Lifesciences has received final approval from the US FDA for Glatiramer Acetate Injection in 20 mg/mL and 40 mg/mL strengths, available as single-dose prefilled syringes. This is an AP-rated substitutable generic of Copaxone, used to treat relapsing forms of Multiple Sclerosis in adults. The product was developed in partnership with Italy-based Chemi S.p.A. and will be manufactured entirely in Europe. Glatiramer Acetate Injection had annual US sales of US$ 719 million (IQVIA MAT Mar-2025), representing a sizeable market opportunity. With this approval, Zydus now has 426 total approvals and has filed 492 ANDAs since FY 2003-04.
Positive for shareholders — the approval opens access to a US$ 719 million market, strengthens Zydus's complex generics portfolio, and is likely to support future US revenue growth once commercial launches begin.