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.
Dr Reddy’s has entered into a settlement agreement with US-based Vivus to end patent litigation related to the latter’s anti-obesity pill Qsymia.
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.
Qysmia is a combination of phentermine and topiramate extended-release sold in capsule form. The drug has gross sales of around USD 73.6 million in 2016.
Dr Reddy’s paid USD 350 million to Israel-based Teva Pharmaceutical Industries in August 2016 to buy a portfolio of eight abbreviated new drug applications (ANDAs) that included Qysmia ANDA as well. Qysima was among the portfolio of overlapping products Teva sold to various companies to get clearance from antitrust regulators to consummate its acquisition Actavis generic business.
The litigation, which has been pending in the US District Court for the District of New Jersey since 2015, resulted from the submission of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration seeking approval to market generic versions of Qsymia.Both Teva and Actavis filed ANDAs with a paragraph IV certification challenging validity of patents held by VIVUS for Qysima in 2015. Dr Reddy’s substituted Teva as defendant in the lawsuit in September 2016.
The first applicant to submit a substantially completed ANDA is given marketing exclusivity.
“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,” said VIVUS in a statement.
“As required by law, VIVUS and Dr Reddy's will submit the settlement agreement to the US Federal Trade Commission and the US Department of Justice for review,” the statement added.
"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,” Seth HZ Fischer, Vivis' Chief Executive Officer said.
“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."
Dr Reddy’s declined to comment citing “terms of the agreement”.Shares of Dr Reddy’s declined 0.51 percent and were trading at Rs 2029.95 at 3.04 pm on BSE, while the benchmark Sensex rose 0.27 percent and was trading at 31,732.83 points.