Xtandi Pricing and Patents: Alternatives To March-In Urged To Lower Medicare, Medicaid Costs

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.

CMS asked to accelerate generic competition To Xtandi. • Source: Shutterstock

The Centers for Medicare and Medicaid Services could authorize lower-cost generic versions of Astellas Pharma US Inc. and Pfizer Inc.’s prostate cancer drug Xtandi in government-sponsored insurance programs using existing federal government licensing and patent rights that are separate from march-in rights, a trio of advocacy organizations argued in a 9 April letter.

Key Takeaways
  • Now that a march-in request for Xtandi has failed again, advocates are pushing alternatives that could accelerate the launch of generic enzalutamide in federal programs.

  • Twenty years ago, one of the provisions was used by the George W. Bush Administration to secure a 50% reduction in the price of Bayer's Cipro as a safeguard against anthrax attacks

The request by Knowledge Ecology International, Universities Allied for Essential Medicines and the Union for Affordable Cancer Treatment is the latest development in an eight-year, so far unsuccessful, campaign by the groups and others to leverage patent

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