Roche's spinal muscular atrophy (SMA) medicine Evrysdi only gained its FDA approval in 2020, but generics companies are already eying the blockbuster as a potential target. After two generics makers filed for potential FDA approvals of copycat Evrysdi products, Roche isn't taking the threat lying down.
Roche has sued Natco Pharma and Zydus Lifesciences for alleged patent infringement after the companies filed for Evrysdi generic nods with the FDA last month. In a new patent lawsuit in New Jersey federal court, the Swiss drugmaker claims Natco's generic infringes five patents while Zydus' infringes three.
The patents in question, which are owned by Roche and Evrysdi’s original maker PTC Therapeutics, cover chemical compounds, methods for treating SMA and formulations of pharmaceutical compositions, according to Roche's lawsuit. They're all expected to expire in the 2030s.
Evrysdi made history in 2020 as the first oral drug approved to treat SMA for adults and children 2 months and older. Since then, the med has also scored an approval to treat infants who are under 2 months old.
In the first 9 months of the year, Evrysdi generated 1.24 billion Swiss francs ($1.4 billion), good for 21% growth compared with the same period in 2023. The SMA treatment competes with Biogen’s spinal injection Spinraza and Novartis’ pricey one-time gene therapy Zolgensma.
Roche is testing the med in combination with its investigational antibody GYM329 in an effort to treat the underlying cause of SMA. A key phase 2 readout is slated for next year, and the combo is included in Roche’s list of key growth drivers beyond 2025. A filing is expected around 2027.
The company chalks Evrysdi up as a part of its “young portfolio,” which is expected to drive growth in the near- to midterm.