Vivus, Inc. said it entered into a settlement agreement with Dr. Reddy’s Laboratories, S.A. and Dr. Reddy’s Laboratories, Inc. resolving patent litigation related to anti-obesity drug Qsymia (phentermine and topiramate extended-release) capsules CIV.
“The litigation, which has been pending in the U.S. District Court for the District of New Jersey since 2015, resulted from the submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration seeking approval to market generic versions of Qsymia,” said Vivus.
“The settlement agreement permits Dr. Reddy’s to begin selling a generic version of Qsymia on June 1, 2025, or earlier under certain circumstances.
“In the event of a launch earlier than June 1, 2025, Vivus will receive a royalty on sales of the generic version of Qsymia.”
This settlement with Dr. Reddy’s concludes all patent litigation brought by Vivus against generic pharmaceutical companies that have filed ANDAs seeking approval to market generic versions of Qsymia.
As required by law, Vivus and Dr. Reddy’s will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
“We are pleased to have concluded all patent litigation that we have brought in the context of the generic availability of Qsymia,” said Vivus CEO Seth Fischer.
“We believe that these settlements underscore the strength of our intellectual property and demonstrate our commitment to defending our existing patents for all our products and technologies.
“We expect to expand our intellectual property estate as we continue to innovate new treatments that improve and extend the lives of patients with serious unmet medical needs.”