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GlaxoSmithKline faces lawsuit over Wellbutrin infringement

Date published: 21/12/2005

Andrx Corp is suing British-based GlaxoSmithKline (GSK) for alleged patent infringements. Andrx claims that GSK's Wellbutrin XL anti-depressant infringes a patent it filed concerning bupropion hydrochloride, the active ingredient in the drug.

The company filed suit in the US District Court of Southern Florida, and is requesting triple damages, as well as the end of manufacturer and removal from sale of Wellbutrin XL. The announcement came after the US Food and Drug Administration (FDA) said it would reinspect Andrx's generic medicine plant in Davie, Florida.

The South Florida Sun-Sentinel reported that a previous visit to the factory in May had found over 100 problems with quality control on the site, including potential product contamination and poor record keeping.

Andrx, which has filed 30 applications for generic drugs with the agency, suspended approval of the applications until it resolved its quality control problems. The delay will affect the company dearly ? putting the 30 drugs into a queue whilst other reviews continue.

An FDA source told the newspaper that the inspection team was being assembled, and that the investigation would begin in either January or Febuary.

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