List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic and Case Agilent Technologies, Inc. Vs Axion Biosystems, Inc.
Contents List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic General information AbbVie to cut drug prices, pledges $100 billion for research Bionpharma Inc. Receives USFDA Approval for Etravirine Tablets Developed in Collaboration with STEERLife Intellectual Property Agilent Technologies, Inc. Vs Axion Biosystems, Inc.: United States District Court for the District of Delaware. List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic The FDA maintains a list of approved new drug applications (NDA) 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. December 2025 lists of off-patent, off-exclusivity drugs without an approved generic are published here. ...