Big Brands Poised To Lose US Marketing Exclusivity In 2019
With the first generic versions of blockbuster brands like Advair, Lyrica, Restasis and Sensipar and the first biosimilars of Herceptin, Avastin and Rituxan expected to launch in the US, 2019 could be a notable year for generics and biosimilars.
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Several generic rivals to Pfizer’s Lyrica have hit the US market following the anti-seizure and pain brand’s loss of exclusivity.
Amgen seeks a preliminary injunction to halt US sales by Cipla and says it will take steps to stop Piramal’s sales; in its antitrust lawsuit, Cipla alleges Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.
Cipla, which previously settled with Amgen, alleges Sensipar's formulation patent is currently unenforceable due to ‘patent misuse,’ and brand sponsor’s deal with Teva following a brief generic launch violates federal antitrust law and California state law.