Nor the Act or the Regulation determines exclusivity. The 5 (or the 3) years exclusivity is the result of as the Law "handle" ANDA:
If an application submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), is approved after the date of the enactment of this subsection, no application may be submitted under this subsection which refers to the drug for which the subsection (b) application was submitted before the expiration of five years from the date of the approval of the application under subsection (b), except that such an application may be submitted under this subsection after the expiration of four years from the date of the approval of the subsection (b) application if it contains a certification of patent invalidity or noninfringement described in subclause (IV) of paragraph (2)(A)(vii).
The Law manage the protection in an indirect way: it does not state any protection, but forbid to file an ANDA. Top of it the Law is about drug and not about indication.
No other result (w/o a new Law ...) exists than NCE from 2012 till 2017.
As the Court ordered FDA is proceeding "consistent with this Opinion" and will issue a new decision / determination. When? It is the question. Maybe it is "linked" to the status of the case, maybe not. Maybe we won't know ever, since the new determination could come out when the case will move. (btw: I expect a Moss ruling re Watson's motion before the Appeal Court deadline for Docs: 8/24.)
We know 2 things only: - it will be NCE and - for 2012-2017
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