USA – FDA Updates List of Off-Patent, Off-Exclusivity Drugs Without Generic Competition

Since 2017, the US Food and Drug Administration (FDA) has been striving to help generic companies understand which brand name drug products are no longer protected by patents or exclusivities and currently have no generic competitors.

The agency, which publishes a list of such ingredients with no generic versions and updates it every six months (in June and December), on Monday offered its latest update, with the removal of 11 ingredients because generic competitors have now entered the market.

The updates were made following the recent approvals of the initial generic versions of the birth control drug mifepristone, the seizure medicine vigabatrin, the breast cancer medicine toremifene citrate and acyclovir cream for the treatment of cold sores…