Lupin Secures US FDA Nod for Siponimod: MS Game-Changer Unlocks $1Bn Market

Approval Details

Lupin announced tentative approval for its ANDA 218228, confirming bioequivalence to Mayzent® Tablets after FDA review of March 2023 filing. Strengths match reference: 0.25mg, 1mg, 2mg oral S1P modulator for adults with relapsing-remitting MS (RRMS), active secondary-progressive MS (SPMS), and clinically isolated syndrome (CIS). Manufactured at approved facilities, launch awaits patent expiry.​

Market & Patent Landscape

Mayzent® generated ~$1.2B US sales (IQVIA est.), targeting Novartis' dominant therapy since 2019 EXPAND trial success. Lupin's Paragraph III certifies non-infringement until '519 patent expires Aug 27, 2028; Paragraph IV challenges '441/'602/'402 patents triggered no litigation stay. This bolsters Lupin's CNS portfolio amid 20+ ANDA filings.​

Key Highlights

Strengths: 0.25mg, 1mg, 2mg tablets (ANDA 218228).​

Indication: Relapsing MS forms (RRMS, active SPMS, CIS).​

Patents: Final approval post-Aug 2028 ('519 expiry).​

Market Size: Mayzent® ~$1.2B annual US sales.​

Sources: US FDA ANDA Letter, Novartis, Lupin