Overview
- Novo Nordisk’s semaglutide patent expires in India on March 20, with more than 50 branded generics expected to launch as early as March 21.
- Analysts project monthly costs for generics at roughly Rs 3,000–5,000, a drop of about 40–80% from the Rs 15,000–25,000 innovators previously charged.
- The CDSCO has barred advertising and influencer-led ‘disease awareness’ promotions, warned against self-administration, and required Risk Management Plans and patient leaflets for new launches.
- Zydus and Lupin announced a licensing and supply pact giving Lupin semi-exclusive rights to co-market Zydus’ semaglutide injection (15 mg/3 ml) with a reusable pen under the brands Semanext and Livarise, alongside Zydus’ Semaglyn, Mashema and Alterme.
- Safety scrutiny is rising internationally, with an FDA warning letter to Novo Nordisk over post-marketing adverse-event reporting, a U.S. wrongful-death lawsuit tied to alleged gastroparesis after Ozempic use, and WHO‑cited reports of counterfeit GLP‑1 drugs circulating globally.