No­var­tis sues FDA over its stance on Sanofi block­buster’s ex­clu­siv­i­ty

No­var­tis’ gener­ic drug sub­sidiary San­doz has sued the FDA, claim­ing the agency is wrong­ly pro­tect­ing Sanofi’s block­buster mul­ti­ple scle­ro­sis drug Auba­gio from gener­ic com­pe­ti­tion.

At is­sue is what’s known as new chem­i­cal en­ti­ty (NCE) ex­clu­siv­i­ty, which is meant to re­ward drug de­vel­op­ers with five years of no com­pe­ti­tion as long as the ac­tive in­gre­di­ent in the re­ward­ed drug is ac­tu­al­ly new.

In this case, San­doz is con­tend­ing that the ac­tive in­gre­di­ent in Auba­gio – ter­i­fluno­mide — has pre­vi­ous­ly been ap­proved in the rheuma­toid arthri­tis drug Ar­a­va, and that FDA is wrong­ful­ly claim­ing that this in­gre­di­ent is just an im­pu­ri­ty in Ar­a­va.

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