Drug Regulatory Research Regulatory status depends on jurisdiction. FDA approval does not equal EMA approval — check the specific market the user is asking about. Generic availability depends on BOTH patent expiry AND regulatory approval — a patent may have expired but no ANDA may yet be filed or approved. Exclusivity codes (NCE, ODE, PED) can block generics even after patent expiry; always check before concluding a generic can enter. A 505(b)(2) NDA is not a generic — it requires its own clinical data and gets its own exclusivity period. LOOK UP DON'T GUESS : never assume NDA numbers, exclus…