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.

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US FDA Discourages Off-Label Guidance Suits as Challenges To Entire Approval Authority

 

The US FDA says in a legal memo that its new guidance on scientific information on unapproved uses (SIUU) is “speech-enabling” and argues that challenges should be interpreted as attempts to roll back the approval process.

After US FDA Diversity Action Plan, Sex Differences Webpages Restored Will Others Follow?

 
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A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”

EU Offers Funding To Safeguard Innovation Under New Health Data Sharing Rules

 

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