ArticleJournal of pharmaceutical policy and practice2021
Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997.
Article in Journal of pharmaceutical policy and practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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
21 citing papers in PubMed.
- Artificial intelligence in drug research and development: a review of methods and applications in drug repurposing.Briefings in bioinformatics · 2026Review
- Comic: explainable drug repurposing via contrastive masking for interpretable connections.BMC bioinformatics · 2026Article
- Computational drug repurposing: approaches, evaluation of in silico resources and case studies.Nature reviews. Drug discovery · 2025Review
- Rare Disease Drug Repurposing.JAMA network open · 2025Article
- A foundation model for clinician-centered drug repurposing.Nature medicine · 2024Article
- Unlocking hidden potential: advancements, approaches, and obstacles in repurposing drugs for cancer therapy.British journal of cancer · 2024Review
- Pathways for non-manufacturers to drive generic drug repurposing for cancer in the U.S.Frontiers in pharmacology · 2024Article
- A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2024Article
- The role of E3 ubiquitin ligases in bone homeostasis and related diseases.Acta pharmaceutica Sinica. B · 2023Review
- Design a Clinical Research Protocol: Influence of Real-World Setting.Healthcare (Basel, Switzerland) · 2023Review
- Repurposing of the Drug Tezosentan for Cancer Therapy.Current issues in molecular biology · 2023Review
- Review
- Beyond "Psychotropic": Repurposing Psychiatric Drugs for COVID-19, Alzheimer's Disease, and Cancer.The Journal of clinical psychiatry · 2023Review
- Repurposing Benztropine, Natamycin, and Nitazoxanide Using Drug Combination and Characterization of Gastric Cancer Cell Lines.Biomedicines · 2023Article
- Review
- Recycled Translation: Repurposing Drugs for Stroke.Translational stroke research · 2022Review
- Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021.JAMA health forum · 2022Article
- Alternative Treatment Strategies for Secondary Bacterial and Fungal Infections Associated with COVID-19.Infectious diseases and therapy · 2022Review
- Diminishing clinical impact for post-approval cancer clinical trials: A retrospective cohort study.PloS one · 2022Article
- Cilostazol for Secondary Stroke Prevention: History, Evidence, Limitations, and Possibilities.Stroke · 2021Review
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
No grant is acknowledged in the PubMed record.
Abstract
backgroundDrug repurposing (i.e., finding novel uses for existing drugs) is essential for maximizing medicines' therapeutic utility, but obtaining regulatory approval for new indications is costly. Policymakers have therefore created temporary indication-specific market exclusivities to incentivize drug innovators to run new clinical investigations. The effectiveness of these exclusivities is poorly understood.
objectiveTo determine whether generic entry impacts the probability of new indication additions.
methodsFor a cohort of all new small-molecule drugs approved by the FDA between July 1997 and May 2020, we tracked new indications added for the subset of drugs that experienced generic entry during the observation period and then analyzed how the probability of a new indication changed with the number of years since/to generic entry.
resultsOf the 197 new drugs that subsequently experienced generic entry, only 64 (32%) had at least one new indication added. The probability of a new indication addition peaked above 4% between 7 and 8 years prior to generic entry and then to dropped to near zero 15 years after FDA approval. We show that the limited duration of exclusivity reduces the number of secondary indications significantly.
conclusionStatus quo for most drug innovators is creating novel one-indication products. Despite indication-specific exclusivities, the imminence of generic entry still has a detectable impact on reducing the chances of new indication additions. There is much room for improvement when it comes to incentivizing clinical investigations for new uses and unlocking existing medicines' full therapeutic potential.
Identifiers
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.