At risk generic entry and impact of formulary status

Regulatory Disputes

In a Hatch-Waxman litigation, a first-to-file generic manufacturer asked CRA to assess changes in formulary status that would result from the at-risk entry and potential exist of its generic asthma product. CRA examined expected formulary repercussions for the branded product from generic entry and removal of the generic product from the market. CRA found that formulary reconsideration would be expected to occur upon removal, resulting in a return to its preferred formulary position. CRA submitted a declaration in the matter. The generic manufacturer was permitted to launch at risk, and it secured a favorable settlement immediately thereafter.

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