Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists

Abstract

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.

Glucagon-Like Peptide-1 Receptor Agonist Use and Residual Gastric Content Before Anesthesia

“…The GLP-1 RA drug market is expected to grow rapidly . Increasing use of GLP-1 RA drugs due to increasing prevalence of diabetes, rising cases of overweight and obesity, off-label use for addiction treatment, and metabolic dysfunction–associated fatty liver disease has fueled the market growth of these drugs .…”

Dispensing of Glucagon-Like Peptide-1 Receptor Agonists to Adolescents and Young Adults, 2020-2023

“…The first 3 are approved for type 2 diabetes in adolescents. All are approved for this indication in adults . Liraglutide and semaglutide are approved for weight management in adolescents and adults .…”

“…Glucagon-like peptide-1 receptor agonists (GLP-1RAs) were approved for type 2 diabetes in 2005 and for weight management in 2014 . Interest in these drugs has surged, spurred partly by the approval of semaglutide for weight management in 2021 …”

GLP-1 Agonists for Obesity—A New Recipe for Success?

“…If all eligible US adults received GLP-1 agonists at discounts, the annual cost would be $600 billion—equal to all other US prescription drug spending combined. There are hopes that competition will lower prices, but each GLP-1 agent is protected by approximately 20 patents, many to 2040 or beyond . Even if current prices decrease, experience with other major drug classes suggests that newer agents in this class will be introduced, with incremental benefits but continuing high prices and aggressive marketing, making it unlikely that total costs will meaningfully decrease soon.…”