It's a coin toss each time, the complexity of the issues are becoming more clear. However, more MAPP's may still be in the process of release before a decision is made. Vascepa has cleared the RLD bar and is now listed instead of TBD. More information doesn't mean ALL the information though. Nothing I've seen in the past 9 months leads me to believe Vascepa doesn't get 5 yrs, but the FDA could make that decision today or 2017.
Ultimately, patents will fend off generic Icosapent and by this time next year Vascepa is likely to have 25 to 30 booked in the OB. Try to find another prescription drug with that kind of IP protection.
"RLD (Reference Listed Drug) Status To Be Determined (TBD)
FDA has not yet determined Reference Listed Drug status for this recently approved product."
Drug Name
Active Ingredients
Strength
Dosage Form/Route
Marketing
Status
RLD
TE
Code
VASCEPA ICOSAPENT ETHYL 1GM CAPSULE; ORAL Prescription Yes None
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