FDA Updates List of Drugs Without Approved Generic Competition

On June 26, 2018, the FDA updated its list of off-patent, off-exclusivity drugs without approved generic competitors to include new drug products and an appendix that identifies new drug application (NDA) products that were removed from the list because one or more abbreviated new drug applications (ANDAs) referencing such NDA drug products have been approved since the previous list publication.

The FDA maintains the list to encourage the development and submission of generic drug ANDAs in markets with little competition and improve transparency. The appendix now lists 11 drugs that previously did not have an approved generic despite the expiry of the reference product’s patents and exclusivity.

There are 2 parts of the list, one listing drugs for which FDA could immediately accept an ANDA without prior discussion, and another that lists drugs with potential legal, regulatory, or scientific issues that would need to be addressed before an ANDA submission. Part 2 includes biological products that are subject to the transition provisions described in the Biologics Price Competition and Innovation Act of 2009.

The list excludes any NDA drugs that have been approved within the past year because it generally is too soon for an ANDA referencing such a product to have been approved, according to an FDA statement.

The FDA first published the list in June 2017 as part of FDA Commissioner Scott Gottlieb’s push to bring more price competition to the market and eliminate a backlog of generic drug applications. The list was updated in December 2017, and added new drugs and reorganized the list based on drug product rather than active ingredients. Additionally, the agency added information about the dosage form for each drug. FDA will update the list every 6 months.

The publication and updating of the list of off-patent, off-exclusivity drugs without approved generic competitors is one step in Commissioner Gottlieb’s Drug Competition Action Plan, which is designed to address what he sees as delays in the approvals of generic drugs by some drug makers who seek to “game” the regulatory system.

According to Rachel Schwartz, director of communications for the Association for Accessible Medicines, the main barrier to developing generics for these products is manufacturing related, as more complex products “require specialty manufacturing processes and facilities” that many generic drug manufacturers do not currently possess.