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31.08.2017 04:38:30

VIVUS Settles With Dr. Reddy's Labs On Qsymia Patent Litigation

(RTTNews) - VIVUS Inc. (VVUS) announced that it has entered into a settlement agreement with Dr. Reddy's Laboratories, S.A. and Dr. Reddy's Laboratories, Inc. resolving patent litigation related to 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 or ANDA to the U.S. Food and Drug Administration seeking approval to market generic versions of 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.

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.

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