Enzalutamide (XTANDI) was developed by Astellas/Medivation and is marketed in the US and other countries under FDA approval (for multiple indications). “Market exclusivity” depends on which country and which type of exclusivity you mean (exclusivity vs. patent life vs. generic “switching” barriers).
United States (FDA) — typical “exclusivity” protections
For new drug products like enzalutamide, the FDA’s main non-patent marketing protections are:
- 5-year New Chemical Entity (NCE) exclusivity (when applicable): covers approval of the active ingredient for the first approved NDA/active ingredient.
- 7-year exclusivity (for some drug products): applies when the application includes conditions like certain new clinical investigations for related indication(s).
- 3-year exclusivity for certain changes (e.g., new formulation, new route, new dosage form, etc.).
However: I can’t reliably state a single fixed “market exclusivity period” date for enzalutamide without knowing:
- Country (US vs EU/UK etc.)
- Which regulatory exclusivity you mean (NCE, 7-year, 3-year, pediatric, orphan, etc.)
- Which indication/product (there are multiple approvals over time, which can affect exclusivity dates)
What I can do next (fast)
If you tell me (a) US, EU/UK, or another country and (b) the specific approval/indication or NDA/BLA you care about, I can pinpoint the relevant exclusivity type(s) and the likely expiration window using the correct regulatory framework (FDA Orange Book / FDA labeling & approval history, or EMA national data exclusivity rules, etc.).
Quick question: Are you asking about US FDA exclusivity specifically, and if so, do you mean NCE exclusivity expiration, or are you thinking of generic market entry barriers (which often involves patents in the Orange Book rather than exclusivity alone)?