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P&G/Watson Macrobid "Authorized" Generic Launch Prompts Mylan Lawsuit

This article was originally published in The Pink Sheet Daily

Executive Summary

The practice of a branded company "authorizing" a generic misleads consumers and undercuts Waxman/Hatch incentives, Mylan says. Watson launched its generic one day after Mylan received ANDA approval and began marketing nitrofurantoin under 180 days of exclusivity.

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Mylan's Legal Fight Against "Authorized" Generics May Shift To Antitrust Attack

Generic firm dismisses lawsuit against FDA seeking a preliminary injunction related to Watson's marketing of a Macrobid "authorized" generic. Dismissal comes shortly before a W.Va. federal judge was expected to rule on claims under the FD&C Act and Administrative Procedures Act. Mylan could revive its lawsuit through antitrust claims.

Mylan's Legal Fight Against "Authorized" Generics May Shift To Antitrust Attack

Generic firm dismisses lawsuit against FDA seeking a preliminary injunction related to Watson's marketing of a Macrobid "authorized" generic. Dismissal comes shortly before a W.Va. federal judge was expected to rule on claims under the FD&C Act and Administrative Procedures Act. Mylan could revive its lawsuit through antitrust claims.

Mylan Sues FDA, Seeks Injunction Against Macrobid “Authorized” Generic

The lawsuit, filed in Clarksburg, W.Va. federal court, says authorized generic deals “deter competition by discouraging challenges to even the weakest patents.”

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