Amarin Corp Plc (AMRN)

[Biobillionair]

For you Dog lovers R/T NCE
"Lisdexamfetamine is a prodrug that is metabolically converted to produce dextroamphetamine, which is responsible for the drug’s activity. Under FDA’s regulation at 21 CFR § 314.108, a non-ester covalently bonded molecule is considered the active moiety ofa drug and, if not previously approved, it will be considered a new chemical entity entitled to 5 years of exclusivity. A non-ester that requires metabolic conversion to produce a previously approved active moiety is considered a new chemical entity. Because lisdexamfetamine is a non-ester covalently bonded molecule, and because it requires metabolic conversion to produce dextroamphetamine, lisdexamfetamine is a new chemical entity and is thus entitled to 5 years of exclusivity.

Camargo has worked on a number of prodrugs and we have found that FDA is consistent in how it makes the determination."


http://blog.camargopharma.com/index.php/2009/10/26/fda-reaffirms-5-year-exclusivity-for-pro-drugs/