Patents and regulatory exclusivities on GLP-1 receptor agonists
Open accessAbstract
Importance: Glucagon-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. Objective: To analyze how manufacturers of brand-name GLP-1 receptor agonists have used the patent and regulatory systems to extend periods of market exclusivity. Evidence Review: The 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. Findings: On 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 Relevance: Patent and regulatory reform is needed to ensure timely generic entry of GLP-1 receptor agonists to the market.
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Brand-name GLP-1 manufacturers have obtained a median of 19.5 patents per GLP-1 receptor agonist and secured a median of 18.3 years of expected protection, with more than half of all patents obtained on delivery devices rather than active ingredients.
“Research has shown that brand-name GLP-1 manufacturers have obtained a median of 19.5 patents per GLP-1 receptor agonist and secured a median of 18.3 years of expected protection, with more than half of all patents obtained on the delivery devices rather than active ingredients [24].”
From Affordable access to GLP-1 obesity medications: strategies to guide market action and policy solutions in the US (2025) · cites this paper as [24]
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“Research has shown that brand-name GLP-1 manufacturers have obtained a median of 19.5 patents per GLP-1 receptor agonist and secured a median of 18.3 years of expected protection, with more than half of all patents obtained on the delivery devices rather than active ingredients [24] .”
Influential
- Authors
- Alhiary, R., Kesselheim, A. S., Gabriele, S., Beall, R. F., Tu, S. S., & Feldman, W. B.
- Affiliations
- Brigham and Women's Hospital (US)
- University of Calgary (CA)
- West Virginia University (US)
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2023-08-15
- Volume
- 330
- Issue
- 7
- Pages
- 650
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC11457043
- OpenAlex
- W4385330768
- Cited by
- 67
- References
- 22
- Citations by year
- 2026: 23 · 2025: 26 · 2024: 16 · 2023: 2
- FWCI
- 13.61
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Gilead Sciences
- West Virginia University
- Arnold Ventures
- National Heart, Lung, and Blood Institute (K08HL163246)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Social Sciences › Business, Management and Accounting › Management of Technology and Innovation › Intellectual Property and Patents
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- GLP-1 receptor agonists, patents, regulatory exclusivity, market exclusivity, generic drug entry, type 2 diabetes, drug delivery devices, patent law reform
- MeSH terms
- Glucagon-Like Peptide-1 Receptor Agonists, Commerce, Diabetes Mellitus, Type 2, Pharmaceutical Preparations, Economic Competition, Humans, Hypoglycemic Agents, Patents as Topic, Therapeutic Equivalency, Time Factors, United States, Drugs, Generic, Drug Approval
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