Mylan Launches First Duragesic Generic
This article was originally published in The Pink Sheet Daily
Executive Summary
ANDA approval comes five days after J&J's pediatric exclusivity on the fentanyl patch expired. Mylan's product will face competition from Sandoz' "authorized" generic.
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Pricing pressure for fentanyl transdermal resulted from "premarketing" by other ANDA filers and regulatory uncertainty that gave "authorized" generic marketer Sandoz an advantage, Mylan CEO says. Timing of other generic entrants and potential supply problems for J&J/Sandoz could allow Mylan to recover lost profits.
Mylan Encounters "Irrational Pricing" In Duragesic Generics Market
Pricing pressure for fentanyl transdermal resulted from "premarketing" by other ANDA filers and regulatory uncertainty that gave "authorized" generic marketer Sandoz an advantage, Mylan CEO says. Timing of other generic entrants and potential supply problems for J&J/Sandoz could allow Mylan to recover lost profits.
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