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The prevalence of post-NDA drug patents and their relationship to the timing of generic approval

Nature Biotechnology volume 42, pages 1350–1355 (2024)Cite this article

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Patent applications filed after a New Drug Application (NDA) is approved are uncommon and do not appear to substantially delay approval of generic drugs in most cases.

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Fig. 1: Time from original FDA approval to generic drug approval for the 28 drugs with post-NDA patents that also had an approved generic drug.
Fig. 2: Time from expiration of last-expiring pre-NDA patent to generic drug approval for 20 drugs with post-NDA patents that also had an approved generic drug.
Fig. 3: Time from expiration of last-expiring pre-NDA patent to 30 September 2020 for the 17 drugs with post-NDA patents and at least one unexpired patent but without an approved generic drug.

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Authors and Affiliations

  1. Program on Regulation, Therapeutics And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA

    Jonathan J. Darrow, Victor Van de Wiele, Beatrice Brown & Aaron S. Kesselheim

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  1. Jonathan J. Darrow
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  2. Victor Van de Wiele
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  3. Beatrice Brown
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  4. Aaron S. Kesselheim
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Correspondence to Jonathan J. Darrow.

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Competing interests

This work was supported by West Health. J.J.D. and A.S.K. have also received support from Arnold Ventures and the Commonwealth Fund and under a Novo Nordisk Foundation grant for a scientifically independent International Collaborative Bioscience Innovation & Law Programme (grant NNF23SA0087056). J.J.D. has also received support from the Greenwall Foundation. V.V.d.W.’s work was partially supported by a grant from the Association for Accessible Medicines.

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Darrow, J.J., Van de Wiele, V., Brown, B. et al. The prevalence of post-NDA drug patents and their relationship to the timing of generic approval. Nat Biotechnol 42, 1350–1355 (2024). https://doi.org/10.1038/s41587-024-02371-4

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