Fluoxetine will have six months of pediatric exclusivity beginning Feb. 2 when Lilly's patent no. 4,314,081 expires. The additional exclusivity is based on clinical data in adolescents aged seven to 17 from two pediatric depression studies, an obsessive compulsive disorder study and a pharmacokinetic study submitted to FDA. If Lilly is granted a rehearing in appeals court or a review in the Supreme Court for its invalidated Prozac patent (No. 4,626,549), which would have expired in 2004, it could delay Barr's 180 days of Waxman/Hatch exclusivity for generic fluoxetine (1"The Pink Sheet" Oct. 30, p. 14)
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.
