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Systematix Research Report
Zydus Lifesciences Ltd. has launched gTrokendi XR (25mg, 50mg and 100mg) in the U.S. The approved doses represent a market size of $175 million. The launch is as per a settlement agreement with the innovator and the market should remain limited competition (one or two players) for a while.
Teva is the other player with whom the innovator has a settlement for a January 2023 launch. However, Teva has not been able to receive a U.S. Food and Drug Administration approval for its generic copy despite having filed the abbreviated new drug application in 2014.
We believe there is a fair chance for Zydus Lifesciences to be the sole player on the market. We estimate gTrokendi XR to add between $40-80 million to the company's U.S. sales.
There are other players which have also filed a Para IV litigation against Trokendi XR, but the earliest timeline of launch is restricted by expiry of the 30 month stay on their respective Para IV filings.
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