Adalvo, in collaboration with its partners, has successfully launched Dapagliflozin film-coated tablets in the UK, marking the first European launch of this blockbuster diabetes and cardiovascular treatment. As an early entry market, the UK is the first step in Adalvo’s broader European expansion.
Following the strategy to clear the way, AstraZeneca requested an interim injunction that was initially refused by the High Court, but the Court of Appeal reversed this decision until final determination of validity. The High Court decided that the Patent is invalid, and that decision was confirmed by the Court of Appeals. The final request for permission to appeal and urgent interim injunctions before the Supreme Court was rejected on 31st July, allowing generics to enter the UK market.
Toni Santamaria, Chief Intellectual Property Officer of Adalvo, commented: "The dapagliflozin case underscores the importance of a proactive 'clearing the way' approach by challenging patent barriers early to enable timely generic entry and improve access to affordable medicines. The UK launch of Dapagliflozin is a significant milestone, highlighting our ability to execute a fast, strategic market entry backed by a strong IP position. "
With total global sales of $14.3 Bn in 2024 (IQVIA), Dapagliflozin is developed based on the reference brand Forxiga, indicated for the treatment of insufficiently controlled type 2 diabetes, symptomatic chronic heart failure, and chronic kidney disease.
This launch highlights Adalvo’s commitment to supporting its partners with a fast, competitive market entry.
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