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

This article was originally published in The Pink Sheet Daily

Executive Summary

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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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.

Teva Takes FDA To Court In Challenge To “Authorized” Generics

The generic firm sues FDA, asserting the agency exceeded its expertise in finding that the marketing of “brand generics” during a first-filer’s 180-day exclusivity period promotes competition. Teva’s lawsuit in D.C. federal court comes two weeks after Mylan filed a separate, but similar, action against FDA in West Virginia.

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