ArticleTherapeutic innovation & regulatory science2026
Patent Term Extension for Innovative Drugs in China: A Cohort Study from 2021 to 2024.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundIn January 2024, China officially implemented the patent term extension (PTE) system, that is, began to implement PTE for innovative drugs approved after June 1, 2021. This study analyzed the PTE system's outcomes in China and its potential impact on drug accessibility.
methodsWe conducted a simulation analysis of the PTE duration and effective patent life after listing (EPLL) of innovative drugs approved by Chinese regulatory authorities from June 2021 to December 2024, using data collected from public databases such as China's marketed drug patent registration platform.
resultsA total of 148 innovative drugs were included in the study. Among them, 61% were able to obtain PTE, with a median PTE duration of 5 years (IQR: 2.3-5). The median EPLL before adding PTE was 9 years (IQR: 6.1-11.7), and the median EPLL after adding PTE was 14 years (IQR: 11.1-14), an increase of 55.6%. Furthermore, the study reveals variations across drug types and therapeutic areas.
conclusionsCompared to findings from prior studies on the U.S. and the European Union, the median PTE duration for innovative drugs in China is longer, while the median EPLL is only marginally extended. Both Chinese domestic stakeholders and foreign enterprises should evaluate the potential impact by considering both the incremental PTE periods and the overall EPLL levels.
Indexed as
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.