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Baker Botts LLP | USA | 11 Jul 2012

Supreme Court paves way for ANDA filers to challenge use codes

On April 17, 2012, the Supreme Court decided Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk AS,1 holding unanimously2 that a generic drug manufacturer may use a specific statute-based counterclaim provision to challenge the accuracy of an innovator’s “use code”a description of patented uses for a brand-name drug.


Baker Botts LLP | USA | 28 Feb 2012

Are branded manufacturers obligated to sell their drugs to generic manufacturers so they can make copies?

Generic drug manufacturers must conduct bioequivalence testing on a proposed drug and its branded counterpart before the generic drug can be approved by FDA.

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