ArticleHealth affairs (Project Hope)2022
Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986-2020.
Article in Health affairs (Project Hope), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed.
- Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone-Salmeterol to Treat Chronic Obstructive Pulmonary Disease.Annals of internal medicine · 2023Trial
- Pharmaceutical products with device-only patents: a cross-sectional analysis.Nature biotechnology · 2026Article
- Tertiary Patents on Drugs Approved by the FDA.JAMA health forum · 2026Article
- Advances in Inhaled Nanoparticle Drug Delivery for Pulmonary Disease Management.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2025Review
- Estimating Costs of Market Exclusivity Extensions For 4 Top-Selling Prescription Drugs in the US.JAMA health forum · 2025Article
- The comparative effectiveness and safety of fluticasone-salmeterol via metered-dose versus dry powder inhalers for COPD: A new user cohort study.PLoS medicine · 2025Article
- Trends in the Cost and Utilization of Publicly Dispensed Respiratory Inhalers in Ontario, Canada: A Repeated Cross-Sectional Study.Pharmacoepidemiology and drug safety · 2025Article
- Out-of-Pocket Prescription Drug Savings for Medicare Beneficiaries with Asthma and COPD Under the Inflation Reduction Act.Journal of general internal medicine · 2025Article
- Out-of-Pocket Savings Under the Inhaler Price Cap.JAMA internal medicine · 2025Article
- Tackling Pharmaceutical Pollution Along the Product Lifecycle: Roles and Responsibilities for Producers, Regulators and Prescribers.Pharmacy (Basel, Switzerland) · 2024Article
- Real-World Use of Inhaled COPD Medications: the Good, the Bad, the Ugly.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2024Article
- Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986-2019.PLoS medicine · 2023Article
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- Article
- Health Care Spending on Respiratory Diseases in the United States, 1996-2016.American journal of respiratory and critical care medicine · 2023Article
- Article
- Patent "Evergreening" of Medicine-Device Combination Products: A Global Perspective.Healthcare policy = Politiques de sante · 2022Article
- Brand-name market exclusivity for nebulizer therapy to treat asthma and COPD.Nature biotechnology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
Inhalers are the mainstay of treatment for asthma and chronic obstructive pulmonary disease (COPD). These products face limited generic competition in the US and remain expensive. To better understand the strategies that brand-name inhaler manufacturers have employed to preserve their market dominance, we analyzed all patents and regulatory exclusivities granted to inhalers approved by the Food and Drug Administration between 1986 and 2020. Of the sixty-two inhalers approved, fifty-three were brand-name products, and these brand-name products had a median of sixteen years of protection from generic competition. Only one inhaler contained an ingredient with a new mechanism of action. More than half of all patents were on the inhaler devices, not the active ingredients or other aspects of these drug-device combinations. Manufacturers augmented periods of brand-name market exclusivity by moving active ingredients from one inhaler device into another ("device hops"). The median time from approval of an originator product to the last-to-expire patent or regulatory exclusivity of branded follow-ons was twenty-eight years (across device hops on fourteen originator products). Regulatory and patent reform is critical to ensure that the rewards bestowed on brand-name inhaler manufacturers better reflect the added clinical benefit of new products.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.