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J&J Duragesic Pediatric Exclusivity Blocks Mylan Generic Until January

Executive Summary

Mylan's generic fentanyl transdermal patch is blocked from launching before January 2005 by J&J/Alza's six-month pediatric exclusivity on Duragesic, FDA said

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Mylan's ability to recoup profits lost to early competitive pricing on Duragesic generics could depend on the timing of other ANDA approvals and Johnson & Johnson's ability to supply an "authorized" generic, CEO Robert Coury said Feb. 3

Mylan Duragesic Generic Launches Into “Irrationally” Priced Market

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FDA Decision On Mylan Duragesic ANDA Upheld By D.C. Court

FDA did not err in barring Mylan's transdermal fentanyl patch from coming to market until after Johnson & Johnson/Alza's pediatric exclusivity for Duragesic expires Jan. 23, a D.C. federal court said

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