Domestic generic major Sun Pharma’s “tentative’’ approval to launch generic diabetes drug Januvia in the US market has raised eyebrows, providing a twist to the patent challenge being fought between the innovator Merck and Glenmark in the country. Sun Pharma, which is a co-partner of Merck’s subsidiary for marketing Januvia in the country, received approval to launch generic Januvia (sitagliptin) in the US recently, indicating that the generic may be setting out to challenge the patent. The approval took many by surprise as US-based Merck holds a patent on Januvia (sitagliptin phosphate) which will expire in 2026. A tentative approval by US Food & Drug Administration is generally construed as an attempt to challenge the patent, and is against the company which has monopoly protection on the drug.
