Louisiana’s Attorney General sues GlaxoSmithKline over delay of generic nasal spray

By Nicole Daniel

In December 2014 Louisiana’s attorney general (AG) filed a complaint against GlaxoSmithKline (GSK) alleging that GSK engaged in an anticompetitive scheme to delay the entry of a generic version of its Flonase nasal spray.

This is the third time since 2011 that AG James D. “Buddy” Caldwell has filed suit against GSK.

The lawsuit alleges that the state’s antitrust and unfair competition laws were violated by GSK by inter alia filing baseless citizen petitions to the US Food and Drug Administration (FDA) in 2004 and 2005 to delay Roxane Laboratories from receiving the necessary regulatory approval to offer a generic version of Flonase nasal spray. In his lawsuit AG Caldwell states that the citizen petitions were filed as part of a “brand maturation strategy” intended to extend GSK’s monopoly and not because of legitimate concerns regarding the safety of the generic nasal spray.

The so-called “brand maturation strategy” included four tactics, i.e. improperly influencing the bioequivalence guidance process of the FDA, the filing of the aforementioned citizen petitions, drafting a fluticasone propionate monograph to submit to the US Pharmacopeia, which lists the test procedures and acceptance criteria to set the standards for quality, purity, strength and consistency of pharmaceutical ingredients in an approved drug and finally supplementing its original New Drug Application to delay the FDA from approving the Abbreviated New Drug Applications before approving GSK’s supplemented original New Drug Application.

The lawsuit alleges that this “brand maturation strategy” resulted in GSK illegally maintaining its monopoly power in the market for fluticasone propionate in the US for a duration of at least 20 months and selling more than a $ 1 billion of Flonase nasal spray during that time. Also the price of Flonase nasal spray was maintained at supra-competitive levels and the state of Louisiana was overcharged by millions of dollars. The state of Louisiana was further deprived of the benefits unrestricted competition offers and of access to less expensive generic versions of Flonase.

The lawsuit seeks restitution and treble damages for an undisclosed amount.

GSK argues that the lawsuit should be moved as it involves a federal agency. This is so since the action centres on alleged conduct of GSK towards a federal agency as well as actions by a federal agency allegedly leading to a delay in approving a generic version of Flonase nasal spray.