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Evaluating The Impact Of The Orphan Drug Act’s Seven-Year Market Exclusivity Period
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What this work says
Outgoing claims: the papers this work cites, builds on, or argues with.
inferredcites →https://doi.org/10.1001/jama.2011.769openalex-snapshot
Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer
inferredcites →https://doi.org/10.1001/jama.2015.10872openalex-snapshot
The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines
inferredcites →https://doi.org/10.1001/jama.297.5.480openalex-snapshot
Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program
inferredcites →https://doi.org/10.1001/jamainternmed.2016.3411openalex-snapshot
Generic Drug Approvals Since the 1984 Hatch-Waxman Act
inferredcites →https://doi.org/10.1002/cpt.426openalex-snapshot
History of Orphan Drug Regulation—United States and Beyond
inferredcites →https://doi.org/10.1016/j.jhealeco.2012.01.004openalex-snapshot
Evergreening, patent challenges, and effective market life in pharmaceuticals
inferredcites →https://doi.org/10.1056/nejmp0908496openalex-snapshot
Balancing Innovation, Access, and Profits — Market Exclusivity for Biologics
inferredcites →https://doi.org/10.1056/nejmp1206573openalex-snapshot
Use Patents, Carve-Outs, and Incentives — A New Battle in the Drug-Patent Wars
inferredcites →https://doi.org/10.1056/nejmp1504672openalex-snapshot
Progress and Hurdles for Follow-on Biologics
inferredcites →https://doi.org/10.1111/j.1468-0009.2011.00636.xopenalex-snapshot
An Empirical Review of Major Legislation Affecting Drug Development: Past Experiences, Effects, and Unintended Consequences
inferredcites →https://doi.org/10.1126/science.1235857openalex-snapshot
Drug Patents at the Supreme Court
inferredcites →https://doi.org/10.1371/journal.pmed.1002190openalex-snapshot
Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage
inferredcites →https://doi.org/10.1371/journal.pone.0049470openalex-snapshot
Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents
inferredcites →https://doi.org/10.1377/hlthaff.2009.1056openalex-snapshot
The Benefits From Giving Makers Of Conventional ‘Small Molecule’ Drugs Longer Exclusivity Over Clinical Trial Data
inferredcites →https://doi.org/10.1377/hlthaff.2016.1340openalex-snapshot
Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers
inferredcites →https://doi.org/10.7326/m16-1432openalex-snapshot
High Generic Drug Prices and Market Competition
What points at this work
Incoming claims: where this work appears in other papers’ reference lists and arguments.
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Market Incentives and the Drug Development Pipeline: Evidence from Antibiotics
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Revenues and Profits From Medicare Patients in Hospitals Participating in the 340B Drug Discount Program, 2013-2016
inferred← citeshttps://doi.org/10.1002/cpt.2625openalex-snapshot
Analysis of Patent and Regulatory Exclusivity for Novel Agents in China and the United States: A Cohort Study of Drugs Approved Between 2018 and 2021
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Intellectual Property Rights and Regulatory Considerations Throughout Drug Repurposing
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The importance of the policy framework on orphan drug accessibility
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Orphan Drugs Offer Larger Health Gains but Less Favorable Cost-effectiveness than Non-orphan Drugs
inferred← citeshttps://doi.org/10.1007/s40258-018-0420-8openalex-snapshot
The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents
inferred← citeshttps://doi.org/10.1007/s40273-020-00934-2openalex-snapshot
Market Exclusivity for Drugs with Multiple Orphan Approvals (1983–2017) and Associated Budget Impact in the US
inferred← citeshttps://doi.org/10.1007/s40290-019-00317-9openalex-snapshot
Effective Market Exclusivity of New Molecular Entities for Rare and Non-rare Diseases
inferred← citeshttps://doi.org/10.1007/s43441-025-00833-8openalex-snapshot
Insights into Support Systems for Orphan Drug Development: A Comparative Study
inferred← citeshttps://doi.org/10.1016/j.ajog.2023.07.042openalex-snapshot
Addressing a broken drug pipeline for preterm birth: why early preterm birth is an orphan disease
inferred← citeshttps://doi.org/10.1016/j.drudis.2018.07.006openalex-snapshot
Patent term restoration for top-selling drugs in the United States
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Incentives for pharmaceutical innovation: What’s working, what’s lacking
inferred← citeshttps://doi.org/10.1016/j.jaad.2019.05.025openalex-snapshot
The impact of the Orphan Drug Act on Food and Drug Administration-approved therapies for rare skin diseases and skin-related cancers
inferred← citeshttps://doi.org/10.1016/j.jval.2020.08.004openalex-snapshot
Modifying the Criteria for Granting Orphan Drug Market Exclusivity
inferred← citeshttps://doi.org/10.1016/j.jval.2021.04.1277openalex-snapshot
Reimagining Pharmaceutical Market Exclusivities: Should the Duration of Guaranteed Monopoly Periods Be Value Based?
inferred← citeshttps://doi.org/10.1016/j.jval.2024.12.009openalex-snapshot
Rare Disease Policy in High-Income Countries: An Overview of Achievements, Challenges, and Solutions
inferred← citeshttps://doi.org/10.1016/j.jval.2025.03.004openalex-snapshot
Twenty-Four Years After the Launch of the EU Orphan Regulation: Analyzing Dutch Price Dynamics, Biosimilars, and Generics for Orphan Medicinal Products
inferred← citeshttps://doi.org/10.1016/j.mayocp.2020.12.041openalex-snapshot
The implications of Industry-Funded Disease Awareness Campaigns in the Rare Disease Setting
inferred← citeshttps://doi.org/10.1016/j.socscimed.2022.115119openalex-snapshot
Market access for medicines treating rare diseases: Association between specialised processes for orphan medicines and funding recommendations
inferred← citeshttps://doi.org/10.1016/s0140-6736(19)33177-0openalex-snapshot
Generating comparative evidence on new drugs and devices after approval
inferred← citeshttps://doi.org/10.1016/s0140-6736(19)33178-2openalex-snapshot
Generating comparative evidence on new drugs and devices before approval
inferred← citeshttps://doi.org/10.1056/nejmp1902943openalex-snapshot
Reforming the Orphan Drug Act for the 21st Century
inferred← citeshttps://doi.org/10.1080/20523211.2024.2436899openalex-snapshot
Reforming the innovation system to deliver affordable medicines: a conceptual framework of pharmaceutical innovation as a complex adaptive system (forest) and theory of change
inferred← citeshttps://doi.org/10.1080/21678707.2021.2047021openalex-snapshot
Drugs and biologics receiving FDA orphan drug designation: an analysis of the most frequently designated products and their repositioning strategies
inferred← citeshttps://doi.org/10.1086/699934openalex-snapshot
The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century
inferred← citeshttps://doi.org/10.1111/cts.13270openalex-snapshot
The economics of moonshots: Value in rare disease drug development
inferred← citeshttps://doi.org/10.1111/hex.13625openalex-snapshot
‘Advocacy groups are the connectors’: Experiences and contributions of rare disease patient organization leaders in advanced neurotherapeutics
inferred← citeshttps://doi.org/10.1136/bmj.m3841openalex-snapshot
Accounting for US public funding in drug development: how can we better balance access, affordability, and innovation?
inferred← citeshttps://doi.org/10.1136/bmjopen-2018-028634openalex-snapshot
Application of orphan drug designation to cancer treatments (2008–2017): a comprehensive and comparative analysis of the USA and EU
inferred← citeshttps://doi.org/10.1177/1073110519840499openalex-snapshot
Approximating Future Generic Entry for New Drugs
inferred← citeshttps://doi.org/10.1177/1073110520979391openalex-snapshot
Generic Competition for Drugs Treating Rare Diseases
inferred← citeshttps://doi.org/10.1177/17534666251411227openalex-snapshot
Advances in orphan drug development for alpha-1 antitrypsin deficiency: a 2025 update from the FDA and EMA
inferred← citeshttps://doi.org/10.1186/s13023-021-01901-6openalex-snapshot
Using four decades of FDA orphan drug designations to describe trends in rare disease drug development: substantial growth seen in development of drugs for rare oncologic, neurologic, and pediatric-onset diseases
inferred← citeshttps://doi.org/10.1186/s13023-022-02317-6openalex-snapshot
The involvement of rare disease patient organisations in therapeutic innovation across rare paediatric neurological conditions: a narrative review
inferred← citeshttps://doi.org/10.1186/s13023-022-02456-wopenalex-snapshot
Lifecycle management of orphan drugs approved in Japan
inferred← citeshttps://doi.org/10.1186/s13023-025-04175-4openalex-snapshot
Trends, lag and characteristics of rare disease drug approval in the USA and China, 1983–2022
inferred← citeshttps://doi.org/10.1186/s40545-020-00282-8openalex-snapshot
Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997
inferred← citeshttps://doi.org/10.12688/f1000research.130388.1openalex-snapshot
Investigation of the diagnostic importance and accuracy of CT in the chest compared to the RT-PCR test for suspected COVID-19 patients in Jordan
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Investigation of the diagnostic importance and accuracy of CT in the chest compared to the RT-PCR test for suspected COVID-19 patients in Jordan
inferred← citeshttps://doi.org/10.12688/f1000research.130809.1openalex-snapshot
Pharmaceutical policy and innovation for rare diseases: A narrative review
inferred← citeshttps://doi.org/10.12688/f1000research.130809.2openalex-snapshot
Pharmaceutical policy and innovation for rare diseases: A narrative review
inferred← citeshttps://doi.org/10.1371/journal.pone.0247853openalex-snapshot
Dynamics of patents, orphan drug designation, licensing, and revenues from drugs for rare diseases: The market expansion of eculizumab
inferred← citeshttps://doi.org/10.1377/hlthaff.2020.01442openalex-snapshot
Spending For Orphan Indications Among Top-Selling Orphan Drugs Approved To Treat Common Diseases
inferred← citeshttps://doi.org/10.1377/hlthaff.2022.00374openalex-snapshot
Understanding ‘Evergreening’: Making Minor Modifications Of Existing Medications To Extend Protections
inferred← citeshttps://doi.org/10.1377/hlthaff.2023.00219openalex-snapshot
Orphan Drug Label Expansions: Analysis Of Subsequent Rare And Common Indication Approvals
inferred← citeshttps://doi.org/10.21019/9781582120904.ch2openalex-snapshot
Chapter 2: The Drug Approval Process
inferred← citeshttps://doi.org/10.2139/ssrn.5086267openalex-snapshot
Incentivizing Drug Rediscovery: Exclusivity Extension and Priority Review for Repurposed Therapeutics
inferred← citeshttps://doi.org/10.23937/2643-4571/1710034openalex-snapshot
Incentives for Pharmaceutical Companies to Develop Treatments for Rare Diseases: A Review of the Literature
inferred← citeshttps://doi.org/10.3389/fmed.2026.1896433openalex-snapshot
Reconceiving orphan drug market exclusivity as a conditional public-law entitlement: a sustainable regulatory governance model with comparative lessons for China
inferred← citeshttps://doi.org/10.3390/ijerph20032483openalex-snapshot
Literature Review on Health Emigration in Rare Diseases—A Machine Learning Perspective
inferred← citeshttps://doi.org/10.3390/jpbi3030015openalex-snapshot
A Decade of Innovation: Medicinal Products with New Active Substances Centrally Authorized Within the EU Between 2011 and 2020
inferred← citeshttps://doi.org/10.3917/jdsam.225.0024openalex-snapshot
Incentives for Pharmaceutical Innovation: What’s Working, What’s Lacking
inferred← citeshttps://doi.org/10.6084/m9.figshare.13520769openalex-snapshot
Additional file 2 of Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997
inferred← citeshttps://doi.org/10.6084/m9.figshare.14759786openalex-snapshot
Additional file 2 of Using four decades of FDA orphan drug designations to describe trends in rare disease drug development: substantial growth seen in development of drugs for rare oncologic, neurologic, and pediatric-onset diseases
inferred← citeshttps://doi.org/10.61554/ijnrph.v4i1.2026.254openalex-snapshot
Orphan versus Standard Drug Approvals: Regulatory Frameworks, Timelines, and Access Challenges - A Comprehensive Review
inferred← citeshttps://doi.org/10.7326/m19-3773openalex-snapshot
Policy Recommendations to Promote Prescription Drug Competition: A Position Paper From the American College of Physicians
inferred← citeshttps://doi.org/10.7759/cureus.80156openalex-snapshot
Drug Price and Health Policy Knowledge Influence Prescription Behavior in Orphan Diseases: Pheochromocytoma and Paraganglioma As Prototypes of Orphan Drug Econometrics
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