Also known as: Lupin
Lupin Limited is an Indian multinational pharmaceutical company headquartered in Mumbai. It focuses heavily on generic medicines across multiple therapeutic areas and serves multiple international markets.
The FDA approved Lupin's generic pitolisant tablets as bioequivalent to WAKIX, and approved Harmony Biosciences' WAKIX for pediatric cataplexy, making it the first non-controlled treatment for both pediatric and adult narcolepsy patients.
Lupin reported record Q3 FY2026 revenue of INR 7,168 crores and a 31.1% EBITDA margin, while preparing to launch a generic semaglutide and shifting focus to innovation. The company also secured US FDA approval for Pegfilgrastim and EU approval for ranibizumab biosimilar.
China has become the dominant source of external drug innovation, with pharma licensing deals reaching $135.7 billion in 2025 and China developing 30% of the world's new innovative drugs. Meanwhile, India is expanding AI use in drug discovery and strengthening its CRDMO and IP infrastructure, though investment gaps persist.
Astellas Pharma reported fiscal 2026 sales of ¥2.14 trillion and net income of ¥291.54 billion, alongside an FDA Priority Review for PADCEV plus Keytruda in muscle-invasive bladder cancer. The company also settled U.S. Myrbetriq patent disputes with Lupin and Zydus. Shares trade at ¥2,470 with mixed valuation signals.
Two new interchangeable Lucentis biosimilars — Lupin's Ranluspec and Formycon/Bioeq's Nufymco — have received FDA approval, while Xbrane's Lucamzi is under review with an October target date. The Lucentis global market was valued at $630 million in 2024.
The global generic drugs market reached $389 billion in 2024 and is projected to grow to $675 billion by 2033. In the U.S., generics account for 91% of prescriptions but only 18% of drug spending, saving over $373 billion annually. Biosimilar adoption remains below 20% despite some products reaching over 60% market share within three years.
Lupin has signed a license and supply agreement with Spektus Pharma to commercialize DeslaFlex, a novel antidepressant for Major Depressive Disorder, in Canada, strengthening its CNS portfolio.
Lupin Limited reported strong Q3 FY26 results with total sales of ₹71,005 million, up 26% year-over-year, and received US FDA approval for its pegfilgrastim biosimilar Armlupeg™, which has not yet been launched.
Dr Reddy's and Biocon plan to launch generic versions of Novo Nordisk's weight-loss drugs at up to 60% below branded prices as semaglutide patents expire, targeting a global market projected to reach $150 billion by the early 2030s.
Zydus Lifesciences resolves US patent litigation with Astellas Pharma over generic Mirabegron for $120 million plus per-unit licensing fees through September 2027, enabling continued US marketing.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT00958633 |
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder. |
TERMINATED | PHASE3 |
