FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, en­thu­si­asm for Amarin’s fish-oil pill Vas­cepa bur­geoned when the FDA signed off on ex­pand­ing the cho­les­terol fight­er’s la­bel to in­clude the drug’s ben­e­fi­cial im­pact on car­dio­vas­cu­lar risk, but months lat­er the ex­u­ber­ance for the block­buster-to-be took a big hit when a judge in­val­i­dat­ed key patents pro­tect­ing Vas­cepa.

De­spite Amarin’s $AM­RN pledge to ap­peal — a process that could take months — the rul­ing opened the door for gener­ic com­pe­ti­tion. Hik­ma Phar­ma­ceu­ti­cals, one of three chal­lengers in the Neva­da suit, on Fri­day said that its gener­ic copy of pure EPA, the omega-3 fat­ty acid that con­sti­tutes Vas­cepa, has been ap­proved by the FDA.

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