Biotech Values

[DewDiligence]

…has FDA ever failed to enforce exclusivity on an approved drug? Like they are doing on KV.A 's Makena.

The FDA’s regulatory authority over compounding pharmacies has always been murky, except in cases where there’s a clear-cut safety problem. (The FDA statement in #msg-68801917 is consistent with the above.) Hence, if compounders are violating KV’s Makena IP, it’s up to the company to take corrective action.

Makena has Orange Book orphan-drug exclusivity until Feb 2018 (http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021945&Product_No=001&table1=OB_Rx ), so FDA can’t approve a generic version until then.