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Mylan Expects Competition From Duragesic “Authorized” Generic In January

This article was originally published in The Pink Sheet Daily

Executive Summary

Mylan’s guidance assumes a Jan. 24 launch of its fentanyl generic “with at least one competitor in the market.” Watson says it anticipates a 2005 launch for its generic.

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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.

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.

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.

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