FDA Awards Six-Month Patent Extension for Lyrica

FDA, MSP News, Rx/Pharmacy on November 30, 2018
Posted by Complex Claims Division

You may recall our earlier blog this week about Lyrica in the News.  Once again, the spotlight is on Lyrica.  First, after Pfizer was awarded a six-month patent extension based on a new pediatric indication for the drug.  Earlier this month, the Supreme Court in the United Kingdom ruled against Pfizer in a longstanding patent litigation involving Lyrica.  As a result of the ruling, the National Health Service in the United Kingdom will likely seek recoupment for overpayments it made for brand name Lyrica instead of lower priced generic equivalents.  Shortly after news broke of the court’s ruling in the United Kingdom, Pfizer announced a nine percent price increase for Lyrica which will take effect in the United States on January 15, 2019.

And now this week, there is another piece of news regarding Lyrica. On Tuesday, the Food and Drug Administration awarded Pfizer a six-month patent extension for Lyrica based upon results of phase III clinical trials in patients with pediatric epilepsy. This means that instead of Lyrica’s patent expiring next month as originally thought, the patent will be extended through June 30, 2019. This is a significant financial win for Pfizer, since sales from Lyrica approximate $3.5 billion in the United States annually.[1] The patent extension will allow Pfizer to preserve some of the revenue which would otherwise have been lost to generic formulations.  It remains to be further seen if this most recent news will impact CMS’ opinion regarding inclusion of Lyrica in approved Medicare Set-asides.  We will continue to post developments as available, here on our blog.


[1] www.pharmamanufacturing.com/industrynews/2018/pfizer-scores-six-month-extension-for-Lyrica-patent. 29 November 2018.