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Mylan’s Duragesic Generic Cannot Escape J&J’s Pediatric Exclusivity – Court

This article was originally published in The Pink Sheet Daily

Executive Summary

D.C. federal judge upholds FDA’s determination that the generic fentanyl patch cannot come to market until after pediatric exclusivity expires in January.

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Sandoz To Market “Authorized” Generic Of J&J Duragesic

FDA is reviewing the merits of citizen petitions regarding approval of generic fentanyl transermal patches, Johnson & Johnson Worldwide Chairman Poon says. The company recommends that investors model greater impact from Duragesic and Concerta generics beyond the first quarter.

Sandoz To Market “Authorized” Generic Of J&J Duragesic

FDA is reviewing the merits of citizen petitions regarding approval of generic fentanyl transermal patches, Johnson & Johnson Worldwide Chairman Poon says. The company recommends that investors model greater impact from Duragesic and Concerta generics beyond the first quarter.

J&J Going Generic? McNeil “Exploratory Project” May Pave The Way

“Patriot” division is appearing at trade shows in an “intelligence-gathering” capacity, McNeil says. An in-house generic operation would provide J&J with a greater share of profits than “authorized” generic deals.

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