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

Regulatory NewsRegulatory News | 24 June 2019 |  By 

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.

FDA said it updates the list to improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.

The list is separated into three sections identifying drugs for which FDA could immediately accept an ANDA without prior discussion, another section identifying drugs for which ANDA development or approval may create legal, regulatory or scientific issues that should be addressed with FDA and an appendix identifying drugs removed from the first two sections of the list because generic competition has been approved since the previous list publication.

When the list was updated last June, Rachel Schwartz, director of communications for the Association for Accessible Medicines, told Focus that many of the products on the list "are likely not candidates for generic engagement because of the specialty nature of the products."

She also said the main barrier to developing generics for some of the listed products is manufacturing-related, as more complex products "require specialty manufacturing processes and facilities" that many generic drug manufacturers do not currently possess.

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

First Generic Drug Approvals


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