Manufacturer Revenue on Inhalers After Expiration of Primary Patents, 2000-2021

Feldman, William B.; Tu, S. Sean; Alhiary, Rasha; Kesselheim, Aaron S.; Wouters, Olivier J.

doi:10.1001/jama.2022.19691

Cited by 9 publications

(1 citation statement)

References 4 publications

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“…Strategies include obtaining large numbers of different patents on the same product, obtaining new patents on products even after FDA approval, and settling patent litigation brought by potential generic competitors. While such patent strategies have been well-documented in the markets for inhalers and insulin pens, this study showed that these practices are also common among GLP-1 receptor agonists . Market exclusivity for top-selling brand-name drugs has a median of about 12 to 14 years, but longer periods have been observed for drug-device combinations, including inhalers (median, 16 years) .…”

Section: Discussionmentioning

confidence: 77%

Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists

Alhiary,

Kesselheim,

Gabriele

et al. 2023

JAMA

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ImportanceGlucagon-like peptide 1 (GLP-1) receptor agonists were first approved for the treatment of type 2 diabetes in 2005. Demand for these drugs has increased rapidly in recent years, as indications have expanded, but they remain expensive.ObjectiveTo analyze how manufacturers of brand-name GLP-1 receptor agonists have used the patent and regulatory systems to extend periods of market exclusivity.Evidence ReviewThe annual US Food and Drug Administration’s (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations was used to identify GLP-1 receptor agonists approved from 2005 to 2021 and to record patents and nonpatent statutory exclusivities listed for each product. Google Patents was used to extract additional data on patents, including whether each was obtained on the delivery device or another aspect of the product. The primary outcome was the duration of expected protection from generic competition, defined as the time elapsed from FDA approval until expiration of the last-to-expire patent or regulatory exclusivity.FindingsOn the 10 GLP-1 receptor agonists included in the cohort, drug manufacturers listed with the FDA a median of 19.5 patents (IQR, 9.0-25.8) per product, including a median of 17 patents (IQR, 8.3-22.8) filed before FDA approval and 1.5 (IQR, 0-2.8) filed after FDA approval. Fifty-four percent of all patents listed on GLP-1 receptor agonists were on the delivery devices rather than active ingredients. Manufacturers augmented patent protection with a median of 2 regulatory exclusivities (IQR, 0-3) obtained at approval and 1 (IQR, 0.3-4.3) added after approval. The median total duration of expected protection after FDA approval, when accounting for both preapproval and postapproval patents and regulatory exclusivities, was 18.3 years (IQR, 16.0-19.4). No generic firm has successfully challenged patents on GLP-1 receptor agonists to gain FDA approval.Conclusions and RelevancePatent and regulatory reform is needed to ensure timely generic entry of GLP-1 receptor agonists to the market.

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