GSK Settles Generic Flonase Law Suits

In IBEW-NECA Local 505 Health & Welfare Plan et al. v. SmithKline Beecham Corp., Eastern District of Pennsylvania Judge Anita B. Brody approved a settlement between GlaxoSmithKline PLK (GSK) and two groups of plaintiffs.  The class action accused the defendant of restraining competition by preventing rivals from marketing generic versions of the allergy medication Flonase.

Direct and indirect Flonase purchasers, as well as generic-drug developer Roxane Laboratories alleged in a series of cases that GSK delayed the entry of generic Flonase and thus increased costs for consumers.  The cost of the steroid nasal spray increased from $60 to $70 per bottle from August 2004 until March 2006, when generic versions finally hit the market.  By 2009, the price had fallen to $20, a drop that plaintiffs alleged would have occurred much sooner had it not been for GSK’s improper conduct.

In October 2002, Roxane sought to introduce generic Flonase.  Just days before the FDA was set to approve Roxane’s application, GSK began filing citizen petitions with the FDA seeking delay until the agency could establish guidelines to determine the bioequivalency of nasal spray products.  Although the FDA rejected GSKs petitions and approved Roxane’s ANDA, the delay had caused prices to remain high longer than they otherwise would have. 

In December 2012, Roxane settled its case with GSK, and another case in the Eastern District of Pennsylvania also just settled.

The terms of the settlement were not disclosed, and the drug company, without admitting wrong-doing, stated that it settled to avoid the expense and uncertainty of litigation.

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