Mylan's Legal Fight Against "Authorized" Generics May Shift To Antitrust Attack
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Teva Legal Challenge Against "Authorized" Generics Rejected By D.C. Court
Any reduction in the economic value of an ANDA first-filer's product during the 180-day exclusivity period "does not rise to the level of absurdity" requiring the court to look beyond the "plain language" of the FD&C Act, D.C. Judge Walton rules. Teva is appealing the decision.
Teva Legal Challenge Against "Authorized" Generics Rejected By D.C. Court
Any reduction in the economic value of an ANDA first-filer's product during the 180-day exclusivity period "does not rise to the level of absurdity" requiring the court to look beyond the "plain language" of the FD&C Act, D.C. Judge Walton rules. Teva is appealing the decision.
"Authorized" Generics Violate Predatory Pricing Laws, Mylan Lawsuit Says
Mylan alleges P&G and Watson violated Robinson-Patman and Sherman antitrust laws by selling an "authorized" generic of Macrobid below cost with the intent to monopolize the market. The lawsuit is aimed at preventing authorized generics during Mylan's 180-day exclusivity period for Norvasc, Levaquin and Ditropan XL.