Evidence map›Paper›PMID 41756505›Full record

ArticleHealth affairs scholar2026

TRIPS, pharmaceutical patents, and generic competition in India.

Margaret K Kyle, Bhaven N Sampat, Kenneth C Shadlen

Abstract read
In one paragraph

Article in Health affairs scholar, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Margaret K KyleCenter for Industrial Economics, Mines Paris - PSL, Paris 75005, France.
Bhaven N SampatSchool of Government and Policy, Johns Hopkins University, 555 Pennsylvania Avenue NW, Washington, D.C. 20001, United States.
Kenneth C ShadlenDepartment of International Development, London School of Economics and Political Science (LSE), London WC2A 2AE, United Kingdom.ORCID https://orcid.org/0000-0003-4010-4835

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: India introduced pharmaceutical patents in response to the 1995 Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Previous studies that focused on older drugs showed limited effects of patents on India's generic market. We examine how a transitional TRIPS provision, which made patents with first global filing (priority) before 1995 ineligible, affected the likelihood of drugs obtaining strong "primary" patents in India, and the subsequent effects on generic competition. Methods: We determined the primary patent priority year (PPPYear) for drugs approved in the United States 1995-2017. For each drug, we gathered Indian patent information and recorded the level of generic competition five years from launch. Results: Primary patents are much more common after PPPYear 1995. Indian generic competition falls approximately 40% after this cutoff, especially for drugs with Indian primary patents. Conclusion: Post-1995 PPPYear drugs are more likely to have primary patents and face less generic competition in India. These drugs now constitute most approvals in India and better reflect the long-run impact of TRIPS than drugs previously examined. The prevalence of drugs in India with primary patents and less competition has important implications for global access to medicines.

Indexed as

competitiongenericsIndiapharmaceutical patentsTRIPS

Identifiers

PMID41756505
PMCPMC12934350

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Registered trials

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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.