Most Counter-Generics Teams Evade Risk of Exclusivity Extension Tactics
50% or more of drug manufacturers prefer competitive tactics and line extensions for their counter-generic strategies
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--A recent Cutting Edge Information study found that pharmaceutical brand companies avoid risk of exclusivity extension tactics.
“Litigation can be costly for branded drug manufacturers and span many years. Pay for delay deals’ legality will be determined on a case-by-case basis, and citizen petitions are under heavy regulatory scrutiny.”
The study, “Post-Patent Generic and Biosimilar Defense: Harnessing Competitive Tactics to Mitigate Revenue Erosion,” revealed that the three categories of counter-generic tactics examined — exclusivity extensions, competitive tactics and line extensions — are not used evenly across branded drug companies.
Competitive tactics and line extensions are the most popular counter-generic strategies used among pharmaceutical companies. About one quarter (26%) of surveyed branded pharmaceutical companies report currently using exclusivity tactics, while 50% or more of companies report currently using both competitive and line extension tactics.
“Some exclusivity extension tactics come with high risk,” said David Richardson, research manager at Cutting Edge Information. “Litigation can be costly for branded drug manufacturers and span many years. Pay for delay deals’ legality will be determined on a case-by-case basis, and citizen petitions are under heavy regulatory scrutiny.”
Some strategies are implemented near the end of the product’s patent. If a company has not planned other tactics and “pay for delay” or citizens petitions are unsuccessful, the drug may be unable to compete with generics. Companies are eager to avoid the risk and uncertainty posed by FDA regulations and litigation. Therefore, competitive and line extension tactics often become more attractive to lifecycle management teams.
“Post-Patent Generic and Biosimilar Defense: Harnessing Competitive Tactics to Mitigate Revenue Erosion,” (http://www.cuttingedgeinfo.com/research/portfolio-management/counter-generics/) profiles more than 15 counter-generics strategies, team structures and staffing, and includes 39 case studies of pharmaceutical companies’ existing approaches to combating generic market entrants.
Use this report to:
- Plan for and implement a diverse and robust set of strategies.
- Build a strong counter-generics task force early.
- Prepare for emerging biosimilar competition and changing approval pathways.
For more information about Counter-Generics and Biosimilars, contact Cassie Demeter at 919-403-6583.