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  • October 8, 2026
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List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

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

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 ANDA referencing that NDA drug product.

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