The timing of the request, with Xtandi’s loss of exclusivity on the horizon, could be explained by the concern that a change in the US presidential administration in 2025 may limit the prospects for near-term relief.

The timing of the request, with Xtandi’s loss of exclusivity on the horizon, could be explained by the concern that a change in the US presidential administration in 2025 may limit the prospects for near-term relief.

Zydus and Lupin are gearing up for the US launch of a generic to Astellas Pharma’s blockbuster drug Myrbetriq (mirabegron) while Aurobindo expects a longer wait. Meanwhile, Torrent is preparing to defend its market share in chronic therapies in India as other companies increasingly target this segment

As the president’s reelection campaign themes take shape, the administration is preparing to leverage NIH patents in ways it had previously eschewed. As with the merger oversight effort, though, the germs of the plans began earlier in Biden’s tenure.