American Pharmaceutical Company Vivus, Inc. has entered into a settlement agreement with Dr Reddy's Laboratories Limited in a patent infringement litigation related to weight management drug Qsymia (phentermine and topiramate extended-release capsules).
The litigation, which has been pending in the district court of New Jersey since 2015, was raised after Dr Reddy's subsidiaries filed the abbreviated new drug application (ANDA) for approval to launch its generic version.
The settlement agreement permits Dr Reddy's to begin selling a generic version of Qsymia on June 1, 2025, or earlier under certain conditions. In the event of a launch earlier than June 1, 2025, the American drug firm will receive a royalty on sales of Qsymia, the company said in a statement.
"We are glad to conclude all patent litigation that we have brought in the context of the generic availability of Qsymia," said Seth H Z Fisher, chief executive officer of Vivus. The drug is approved in the US and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a certain body mass.
Dr Reddy's wins a patent infringement case in the US
In a yet another development, the US court for the district of Delaware issued a judgment in favour of Dr Reddy's Laboratories Limited, ruling that the proposed generic version of Suboxone sublingual film does not infringe US patent as asserted by Indivior.
"We are pleased with the verdict passed by the US District Court of Delaware in Dr Reddy's favour, on the patent litigation of the drug Suboxone. The judgment reiterates our commitment to providing affordable and innovative medicines that address the unmet and under-met needs of patients around the world," Dr Reddy's spokesperson said in a statement.
In December 2014, Reckitt Benckiser demerged its pharmaceuticals business as Indivior.
Dr Reddy's scrip jumped 9.75 per cent or Rs 196.95 to close at Rs 2,217.35 on Bombay Stock Exchange on Friday.