Babak Sahragardjoonegani1, Reed F Beall2,3, Aaron S Kesselheim3, Aidan Hollis4. 1. Department of Economics, University of Calgary, 527 Campus Place N.W., Calgary, AB, T2N 4Z6, Canada. 2. Department of Community Health Sciences, Cumming School of Medicine and O'Brien Institute for Public Health, University of Calgary, 3280 Hospital Drive NW, Calgary, AB, T2N 4Z6, Canada. 3. Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital / Harvard Medical School, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA. 4. Department of Economics, University of Calgary, 527 Campus Place N.W., Calgary, AB, T2N 4Z6, Canada. ahollis@ucalgary.ca.
Abstract
BACKGROUND: Drug 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. OBJECTIVE: To determine whether generic entry impacts the probability of new indication additions. METHODS: For 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. RESULTS: Of 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. CONCLUSION: Status 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.
BACKGROUND: Drug 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. OBJECTIVE: To determine whether generic entry impacts the probability of new indication additions. METHODS: For 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. RESULTS: Of 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. CONCLUSION: Status 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.
Authors: H Christine Allen; M Connor Garbe; Julie Lees; Naila Aziz; Hala Chaaban; Jamie L Miller; Peter Johnson; Stephanie DeLeon Journal: J Okla State Med Assoc Date: 2018-10
Authors: Adam de Havenon; Kevin N Sheth; Tracy E Madsen; Karen C Johnston; Tanya N Turan; Kazunori Toyoda; Jordan J Elm; Joanna M Wardlaw; S Claiborne Johnston; Olajide A Williams; Ashkan Shoamanesh; Maarten G Lansberg Journal: Stroke Date: 2021-09-14 Impact factor: 10.170
Authors: Charlotte Asker-Hagelberg; Tomas Boran; Christelle Bouygues; Sini Marika Eskola; Laszlo Helmle; César Hernández; François Houýez; Helen Lee; Dimitra D Lingri; Laurent Louette; Lydie Meheus; Wim Penninckx; Beata Stepniewska Journal: Front Med (Lausanne) Date: 2022-01-10