FDA Re-Evaluates Orange Book Patents
US Agency Mulls Orange Book Listing For Device, REMS, Digital App Patents
With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.
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Agency is considering whether patents for digital apps used in conjunction with approved drugs should be listed in the 'Orange Book’; modernization plan for the compendium includes new guidance on therapeutic equivalence ratings to help clarify path for fully substitutable 505(b)(2) NDA products.
Commissioner says agency will modernize drug patent reference manual this year and consider potential changes to Orange Book administration policy. However, any transformative moves could trigger a court challenge.
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