Winning approval for a new drug is just the beginning. To maximize a therapy's benefits, drugmakers must continue improving the product life cycle to reach more patients. These life cycle extension initiatives enhance the value of a molecule for both patients and manufacturers but require specialized capabilities. The commercial benefits are clear: in Europe, innovator products enjoy eight years of data exclusivity and an additional two years of market protection, preventing competitors from using their data or selling rival products. The US offers similar protections.
Medically, life cycle extensions are compelling. Post-approval, companies can improve safety, effectiveness, and convenience by introducing new strengths, indications, or fixed-dose combinations. For more insights, read our whitepaper.
