Bayer's ‘053 patent on its drug Xarelto® expires in November 2024, and Bayer granted Mylan a covenant not to sue. Bayer has a second patent that is subject to a pediatric exclusivity that expires later.
Bayer's ‘053 patent on its drug Xarelto® expires in November 2024, and Bayer granted Mylan a covenant not to sue. Bayer has a second patent that is subject to a pediatric exclusivity.
The Hatch-Waxman Act allows a generic drugmaker to rely on a branded drugmaker’s Food and Drug Administration-approved New Drug Application if the generic drugmaker can show that the.
FTC Requires Correct Listing of Patents in FDA Orange Book natlawreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from natlawreview.com Daily Mail and Mail on Sunday newspapers.
The Hatch-Waxman Act (“the Act”) was designed to strike a delicate balance between pharmaceutical innovation and faster access to affordable drugs. However, one aspect of the Act, the patent listing process, when used improperly, can knock this balance out of whack.