FDA Adds Patent Declaration Forms For Innovators To Generic Final Rule
This article was originally published in The Tan Sheet
Patent declaration forms must be used for Orange Book submission of patent information under FDA's generic reform final rule
You may also be interested in...
Patent information in currently pending NDAs may not fall under the jurisdiction of FDA's final rule on generic drugs
FDA's final rule to reform Hatch/Waxman requires an innovator company to test data to establish that a polymorph claimed in a patent is the same as the active ingredient in the NDA
A bipartisan Senate bill would encourage earlier ANDA filings by generics firms to head off new innovator patent listings and secure sole rights to 180-day exclusivity