Ad­di­tion­al ex­clu­siv­i­ty for a can­cer treat­ment could cost the pub­lic $3 bil­lion, an­a­lyst says

Last week, the FDA grant­ed ad­di­tion­al ex­clu­siv­i­ty to Ea­gle Phar­ma­ceu­ti­cals’ can­cer med­i­cine Tre­an­da (ben­damus­tine hy­drochlo­ride), a de­ci­sion that ef­fec­tive­ly halts the in­tro­duc­tion of gener­ic ver­sions of the in­jec­tion un­til 2022, which one an­a­lyst said could cost the pub­lic $3 bil­lion.

The de­ci­sion by the FDA comes as the com­pa­ny’s oth­er ben­damus­tine hy­drochlo­ride prod­uct, known as Ben­de­ka, won sev­en years of or­phan drug ex­clu­siv­i­ty last sum­mer be­cause of a US dis­trict court win for the com­pa­ny against the FDA.

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