During the first case management of this case in the Federal Court of Australia on 14 May 2024, it became clear that Cipla is challenging the patent term extension (PTE) on Novo Nordisk’s liraglutide formulation patent (AU 2004290862). The 9-month PTE was granted on 4 August 2011 and is due to expire on 26 August 2025. If Cipla succeeds in its challenge, the expiry date will become 18 November 2024.
According to submissions made in open Court, pending timely and favourable resolution of its challenge, Cipla plans to launch liraglutide biosimilar on 19 November 2024.
A three-day substantive hearing has been scheduled for the end of October 2024.
This follows the Indian launch of a liraglutide biosimilar, Glenmark’s Lirafit® in January this year and the approval in the UK of Biocon’s liraglutide biosimilar in March 2024.