Estimating the Value of Adding 30 Days to the 180-Day Market Exclusivity of the First-to-File Generic Drug Manufacturer
The value of an additional month of exclusivity to a generic firm is sizable and could entice more generic companies on the margin to take on the risk of patent challenges, especially in large markets.
Authors
- Sean Klein
- Zeid El-Kilani
- Sonal Parasrampuria
- Ruben Jacobo-Rubio
- Aylin Sertkaya (ORCID: https://orcid.org/0000-0001-5830-649X)
- Andreas Lord
Institutions
- United States Food and Drug Administration (US)
- Office of the Assistant Secretary for Planning and Evaluation (US)
- Eastern Research Group (United States) (US)
- Carnegie Mellon University (US)
Publication Details
- Journal
- PharmacoEconomics - Open
- Published
- 2025-09-26
- DOI
- https://doi.org/10.1007/s41669-025-00607-w
- Primary Topic
- Pharmaceutical Economics and Policy
- Type
- article
- Field-Weighted Citation Impact
- 0.00