RESUMO
This cross-sectional study identifies the prevalence of patents on risk evaluation and mitigation strategies and their association with delaying generic competition.
Assuntos
Medicamentos Genéricos , Patentes como Assunto , Medicamentos sob Prescrição , Avaliação de Risco e Mitigação , Custos de Medicamentos , Indústria Farmacêutica , Medicamentos Genéricos/uso terapêutico , Competição Econômica , Avaliação de Risco e Mitigação/legislação & jurisprudência , Estados Unidos , Patentes como Assunto/legislação & jurisprudênciaRESUMO
This study examines all patents associated with biologic litigation to understand how manufacturers use ancillary product patents to delay biosimilar market entry.
Assuntos
Produtos Biológicos , Medicamentos Biossimilares , Patentes como Assunto , Produtos Biológicos/uso terapêutico , Aprovação de Drogas , Indústria Farmacêutica , Competição Econômica , Estados Unidos , Fatores de TempoRESUMO
This study assesses the frequency of continuation patents on brand-name drugs approved by the US Food and Drug Administration from 2000 to 2015.
Assuntos
Custos de Medicamentos , Competição Econômica , Patentes como Assunto , Aprovação de Drogas/estatística & dados numéricos , Custos de Medicamentos/estatística & dados numéricos , Medicamentos Genéricos/uso terapêutico , Estados Unidos/epidemiologia , United States Food and Drug Administration , Patentes como Assunto/estatística & dados numéricosRESUMO
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.
Assuntos
Diabetes Mellitus Tipo 2 , Aprovação de Drogas , Medicamentos Genéricos , Receptor do Peptídeo Semelhante ao Glucagon 1 , Hipoglicemiantes , Patentes como Assunto , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/economia , Aprovação de Drogas/legislação & jurisprudência , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Preparações Farmacêuticas/economia , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Patentes como Assunto/legislação & jurisprudência , Estados Unidos , Equivalência Terapêutica , Comércio , Competição Econômica/economia , Competição Econômica/legislação & jurisprudência , Fatores de TempoRESUMO
This study evaluates sales revenue earned in the first 5 years for newly marketed brand-name drugs with and without an initial orphan drug designation.
Assuntos
Comércio , Produção de Droga sem Interesse Comercial , Medicamentos sob Prescrição , Comércio/economia , Comércio/legislação & jurisprudência , Comércio/estatística & dados numéricos , Comércio/tendências , Legislação de Medicamentos/economia , Legislação de Medicamentos/estatística & dados numéricos , Marketing/economia , Marketing/legislação & jurisprudência , Marketing/estatística & dados numéricos , Produção de Droga sem Interesse Comercial/economia , Produção de Droga sem Interesse Comercial/legislação & jurisprudência , Produção de Droga sem Interesse Comercial/estatística & dados numéricos , Medicamentos sob Prescrição/economia , Estados Unidos/epidemiologiaAssuntos
Medicamentos Biossimilares , Indústria Farmacêutica , Medicamentos Genéricos , Competição Econômica , Patentes como Assunto , Humanos , Medicamentos Biossimilares/economia , Medicamentos Biossimilares/uso terapêutico , Custos de Medicamentos , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Indústria Farmacêutica/economia , Indústria Farmacêutica/legislação & jurisprudência , Patentes como Assunto/legislação & jurisprudência , Competição Econômica/economia , Competição Econômica/legislação & jurisprudênciaRESUMO
BACKGROUND: Patients with asthma and COPD rely on inhalers to control symptoms. Yet, these products remain expensive, in part because brand-name manufacturers have obtained numerous patents on inhalers, including on their delivery devices. Recent antitrust litigation has raised questions about the boundaries of listing device patents with the US Food and Drug Administration (FDA), particularly when patents do not claim any active ingredients. RESEARCH QUESTION: How have manufacturers relied on device patents to preserve market exclusivity on brand-name inhalers? STUDY DESIGN AND METHODS: We identified patents on brand-name inhalers approved for asthma and COPD between 1986 and 2020 using the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). We extracted information about patents from LexisNexis TotalPatent One and Google Patents and searched device patents for mention of active ingredients or other prespecified features linking the patent to the relevant drug. For each inhaler, we determined the duration of protection added by device patents. RESULTS: The FDA approved 53 brand-name inhalers for asthma and COPD from 1986 through 2020, 39 of which had at least one device patent. One hundred thirty-seven distinct device patents were in the final cohort, representing 49% of all patents listed on inhalers. Seventy-seven percent of device patents made no mention of active ingredients or their molecular structures, and 72% made no mention of any relevant prespecified feature connecting the device patent to the drug product. For the 39 brand-name inhalers with one or more device patents listed in the Orange Book, device patents extended the duration of market protection by a median of 5.5 years (interquartile range, 0.0-10.5 years) beyond the last-to-expire nondevice patent. INTERPRETATION: Patent and regulatory reform is needed to promote generic competition and to ensure that patients with asthma and COPD have access to affordable medications.
Assuntos
Asma , Doença Pulmonar Obstrutiva Crônica , Humanos , Indústria Farmacêutica , Preparações Farmacêuticas , Nebulizadores e Vaporizadores , Asma/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológicoRESUMO
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.
Assuntos
Indústria Farmacêutica , Competição Econômica , Nebulizadores e Vaporizadores , Patentes como Assunto , Medicamentos Genéricos , Competição Econômica/economia , Nebulizadores e Vaporizadores/economia , Estados Unidos , Patentes como Assunto/legislação & jurisprudência , Indústria Farmacêutica/economia , Indústria Farmacêutica/legislação & jurisprudênciaRESUMO
This Viewpoint discusses 3 bills introduced recently in Congress that focus on patent eligibility, fraud, and quality and that have major implications for clinical medicine and pharmaceutical development.
Assuntos
Reforma dos Serviços de Saúde , Legislação de Medicamentos , Patentes como Assunto , Medicamentos sob Prescrição , Reforma dos Serviços de Saúde/legislação & jurisprudência , Estados Unidos , Patentes como Assunto/legislação & jurisprudênciaRESUMO
This cohort study assesses the frequency of approval and marketing of skinny-label biosimilars and their savings to Medicare.