Modification Patents Across Multiple NDAs in Pharmaceutical Protections
Clicks: 1
ID: 314518
2026
Article Quality & Performance Metrics
Overall Quality
Not rated
Combines reader engagement with the AI quality analysis. This
article has not been analysed, so there is no overall score —
reader engagement is measured and shown alongside.
Reader Engagement
0.0
/100
1 views
0 readers
AI Quality Assessment
Not analyzed
Readership in this journal
Ranked #59 of 91 articles by views in Health Affairs Scholar
Most read
Least read
Bar heights use a square-root scale.
Mint this article as an NFT
Not yet mintedCreate a permanent, verifiable on-chain record of this article on the Scimatic Network. The NFT is held in your Journament account, and you can withdraw it to your own wallet at any time.
5
SUSD
one-off · no wallet required
Abstract
Abstract Introduction Our study examines modification patents across multiple NDAs, employed by pharmaceutical companies to extend patent protections. Ours is the only comprehensive study of modification patents by API across multiple NDAs, the approach of current regulatory initiatives, investigating how these patents extend drug protections and impede generic entry. Methods We examine 1,028 modification patents, categorizing them as chemical variations, formulation changes, treatment methods, or device/agent. We tabulated additional granted protection time, correlations with new NDAs, and potential generics’ litigation. Results On average, five modification patents protected each drug, extending granted protection periods by 10.9 years. Examining market outcomes for the 199 drugs with generics approved by August 2025, or whose primary patents had expired by then, modification patents provided a median of 2.3 years’ median effective additional protection time before generic entry. 89% of drugs’ protection periods were extended by modification patenting in some dimension. 58% had a modification patent associated with a new NDA, and 70% had at least one modification patent in Paragraph IV-related litigation. Conclusion These findings suggest we reconsider societal resources dedicated to modification patenting, generally and during clinical decision-making. Hope for regulatory and legislative reform lies in a ‘one-and-done’ policy and restricting certain patent types.
| Reference Key |
openalex_W7162022391
Use this key to autocite in the manuscript while using
SciMatic Manuscript Manager or Thesis Manager
|
|---|---|
| Authors | Robin Feldman, Ramy Alsaffar, Tanziuzzaman Sakib |
| Journal | Health Affairs Scholar |
| Year | 2026 |
| DOI |
10.1093/haschl/qxag123
|
| URL | |
| Keywords | Keywords not found |
Citations
No citations found. To add a citation, contact the admin at info@scimatic.org
Comments
No comments yet. Be the first to comment on this article.