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SBsandman

05/03/20 3:05 PM

#271115 RE: Jasbg #271113

Jasbg-

I’m not a lawyer but the answers are somewhat straightforward (at least I think).

AMRN’s exclusivity granted by FDA for the Marine indication expired. Their patents were still valid til 2030 of thereabouts.

Generics filed ANDAs with the FDA bc the exclusivity had expired. This in turn required AMRN to sue for infringement on their Marine patents. Thus AMRN was the plaintiff and the generics were defendants.

AMRN’s exclusivity for RIT indication expires 3 years after its approval last fall which means generics could submit ANDAs for that indication as well. AMRN’s patents would have to hold up in court.

Sb