Hyderabad: Nasdaq-listed Vivus Inc on Thursday entered into a settlement agreement with Dr Reddy’s Laboratories to resolve a long-pending patent litigation related to weight management capsules Qsymia.
According to a statement issued by the US-based drug maker, the litigation, pending since 2015, resulted from the submission of an abbreviated new drug application (Anda) by Dr. Reddy’s seeking approval to market generic versions of Qsymia.
The settlement permits the city-based drugmaker to begin selling a generic version of Qsymia from June 2025, or earlier under certain circumstances. In the event of an early launch, Vivus will receive a royalty on sales of the generic version of the drug.
Qsymia (phentermine and topiramate extended-release) capsules CIV is used to manage chronic overweight in adults with obesity symptoms.
This settlement concludes all patent litigation brought by Vivus against generic pharma companies that have filed Andas seeking approval to market generic versions of Qsymia.
As required by US laws, Vivus and Dr. Reddy’s will submit the settlement agreement to the US Federal Trade Commission and US Department of Justice for review.
“We are pleased to have concluded all patent litigations that we have brought in the context of the generic availability of Qsymia. We believe these settlements underscore the strength of our intellectual property and demonstrate our commitment to defending our existing patents for all our products and technologies,” Seth Fischer, chief executive of Vivus said in a statement.
A spokesman of Dr Reddy’s refused to comment on the settlement.