ABSTRACT
This study analyzed the US Food and Drug Administrationlisted patents on glucagon-like peptide 1 (GLP-1) receptor agonists to determine their claim characteristics and the potential barriers they pose to generic entry.
Subject(s)
Diabetes Mellitus, Type 2 , Glucagon-Like Peptide-1 Receptor Agonists , Hypoglycemic Agents , Medical Device Legislation , Patents as Topic , Humans , Diabetes Mellitus, Type 2/drug therapy , Glucagon-Like Peptide 1/agonists , Glucagon-Like Peptide-1 Receptor/agonists , Glucagon-Like Peptide-1 Receptor Agonists/administration & dosage , Glucagon-Like Peptide-1 Receptor Agonists/therapeutic use , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/therapeutic useABSTRACT
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.
Subject(s)
Diabetes Mellitus, Type 2 , Drug Approval , Drugs, Generic , Glucagon-Like Peptide-1 Receptor , Hypoglycemic Agents , Patents as Topic , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/economics , Drug Approval/legislation & jurisprudence , Drugs, Generic/economics , Drugs, Generic/therapeutic use , Glucagon-Like Peptide-1 Receptor/agonists , Pharmaceutical Preparations/economics , Hypoglycemic Agents/economics , Hypoglycemic Agents/therapeutic use , Patents as Topic/legislation & jurisprudence , United States , Therapeutic Equivalency , Commerce , Economic Competition/economics , Economic Competition/legislation & jurisprudence , Time FactorsABSTRACT
This study quantifies the revenue earned on all brand-name inhalers approved by the US Food and Drug Administration from 2000 to 2021 and compared earnings before and after expiration of primary patents on these products.
