US: List of off-patent, off-exclusivity drugs without an approved generic

27-06-2019

US: List of off-patent, off-exclusivity drugs without an approved generic

(Source: US FDA 2019-06-28)

The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. The FDA updates this list every six months (in June and December) to improve transparency and encourage the development and submission of ANDAs in markets with little competition.

The list is separated into three sections:

● Part I identifies those drug products for which FDA could immediately accept an ANDA without prior discussion.

● Part II identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA.

● The Appendix identifies NDA drug products that were removed from Part I or Part II of the list because one or more ANDAs referencing such NDA drug products have been approved since the previous list publication.

Please refer to the PDF version of the list for full details and methodology.

To continue reading this article please go to US FDA

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

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