Ask Janet Woodcock M.D., Director (CDER), Food and Drug Administration
VASCEPA 1GM ICOSAPENT ETHYL CAPSULE; ORAL
FDA’s regulation at 21 CFR 314.108, a non ester covalently bonded molecule is considered the active moiety of a drug, it will be considered a New Chemical Entity entitled to 5 years of exclusivity. Non Ester that requires metabolic conversion to produce previously approved active moiety is considered a New Chemical Entity.
When exclusivity attaches to an active moiety or to an innovative change in an already approved drug, the submission or effective date of approval of ANDA’s and 505(b)(2) applications for a drug with that active moiety or innovative change will be delayed until the innovator’s exclusivity has expired, In case of Lovaza the 5 years exclusivity was expired before Vascepa ANDA's and considered as subsequent versions of the drugs which is entitled to exclusivity, and regardless of the specific listed drug product to which the ANDA or 505(b)(2) application refers.