A survey of drug manufacturers finds that brand teams frequently wait until 2 years prior to patent expiration before planning for generic entrants.
RESEARCH TRIANGLE PARK, N.C., May 06, 2013 (BUSINESS WIRE) — Brand teams at 44% of pharmaceutical companies wait until two years out from patent expiry to begin planning for generic competitors. Unfortunately, with such little time to prepare, brand teams are often too late to properly implement an extensive counter-generics strategy, according to a new Cutting Edge Information study.
The generics defense study, “Post-Patent Generic and Biosimilar Defense Strategies,” found that a few last-ditch strategies, such as lowering prices, can be effective. Many of the big revenue-protecting strategies, however, require more than two years to prepare and implement. Any market share retained from late-stage tactics will be a fraction of what it could have been preserved had planning begun earlier.
New formulations tactics, for example, should begin 7-10 years prior to patent expiration. The exact timing may vary by product, depending on its status as ether a first-to-market drug, an orphan product, a small-molecule or a biosimilar, etc. However, the general directive is the same: To execute many effective tactics, brand teams must include adequate planning time early in the process. An early start allows for multiple contingency plans in case one tactic does not succeed.
“The most successful way to maximize a product’s market share for as long as possible requires coordinating multiple tactics, which takes time and resources,” said Michelle Vitko, senior research analyst at Cutting Edge Information. “Many potentially high-return tactics, such as new drug formulations or next-generation drugs, need years of clinical development to be ready for launch once the product loses its patent. Likewise, receiving approval for an OTC switch or establishing a generic subsidiary requires more than two years before expiry.”
“Post-Patent Generic and Biosimilar Defense: Harnessing Competitive Tactics to Mitigate Revenue Erosion” (http://www.cuttingedgeinfo.com/research/portfolio-management/counter-generics/) explores generic pharma strategies for Top 10, Top 50 and small pharmas. The report profiles more than 15 counter-generics strategies, team structures and staffing, and includes 39 new case studies of companies’ approaches to combating generics.
Use this report to:
- Plan for and implement a diverse and robust set of strategies.
- Build a strong counter-generics task force.
- Prepare for emerging biosimilar competition and changing approval pathways
Source: Market Watch, Business Wire