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

 
• By Cathy Kelly
  
Generate a summary of this article
Listen to this article
Beta

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.

The request by Knowledge Ecology International, Universities Allied for Essential Medicines and the Union for Affordable Cancer Treatment is the...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Patents

Divisional Patents Remain Divisive In Europe

 
• By David Wallace

Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.

US Patent Office Plan To Expand Settlement Disclosure Requirements Welcomed By FTC

 
• By Cathy Kelly

US Federal Trade Commission says the policy would enhance its ability to detect reverse payment settlements between pharmaceutical companies that raise antitrust concerns.

Industry Calls For More Clarity On EU Compulsory Licensing Proposal

 
• By Francesca Bruce

Industry groups say the initiative will undermine innovation and the competitiveness of European companies, impeding Europe's ability to tackle future crises effectively.

Bolar Exemption India Files: Roche Blocks Alleged Infringer Of Evrysdi Patent

 
• By Anju Ghangurde

More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance warding off a local drug maker in the Evrysdi patent infringement case.

More from Legal & IP

Overcoming The Challenges Of Developing Hearing Loss Therapies

 
• By Ian Schofield

Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.

HRSA-J&J Dispute Over 340B Rebate Plan Again Underscores Need For Program Reform

 
• By Cathy Kelly

Johnson & Johnson plans to shift 340B price concessions on Stelara and Xarelto to rebates for some hospitals beginning in October, allowing for more company oversight of claims.

MSN Generic Entresto Launch In Doubt After US Appeals Court Stops Approval

 
• By Dean Rudge

MSN Laboratories will be unable to move forward with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US for now after the originator won a stay of the firm’s ANDA approval pending appeal from the US Court of Appeals for the District of Columbia Circuit.