Advocacy groups are urging the Biden administration to use federal authority to license patents for the prostate cancer drug Xtandi (enzalutamide), developed by Astellas ($ALPMY) and Pfizer ($PFE), to allow for generic manufacturing. This move aims to lower the cost of the medication, which is listed in the FDA Orange Book. The request specifically calls for a Bayh-Dole Section 202 license and a 28 USC 1498 authorization. The effort is seen as a strategy to reduce the financial burden on Medicare and Medicaid by making cheaper generic versions available before the original patents and exclusivity expire.
Odds that this is the route that allows generics through earlier than patent/exclusivity expiry? #pinksheet #pharma: Xtandi Pricing and Patents: Alternatives To March-In Urged To Lower Medicare, Medicaid Costs https://t.co/tpqWja2vhc
Xtandi Pricing and Patents: Alternatives To March-In Urged To Lower Medicare, Medicaid Costs https://t.co/DdgzG3iqxl #PinkSheet
In the latest gambit to lower the cost of a pricey cancer medicine, three advocacy groups are pushing the Biden administration to use federal laws to license Xtandi patents. https://t.co/6XW44qHL7w
Biden administration urged to license prostate cancer drug patents in a bid to lower its cost.. https://t.co/rdGVkjDJC7 #pharma #biotech #cancer #patents #Xtandi $PFE $ALPMY
The Biden administration is facing a new call to use its government authority to license an Astellas and Pfizer prostate cancer drug for generic manufacturing. https://t.co/X31KAnyUHx
Request for CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498 authorization and consent to use three patents listed in the FDA Orange Book for the cancer drug enzalutamide https://t.co/vtTVP0elwc