Merck & Co sues Impax Labs over Vytorin patent infringement in USA, as firm faces 'patent cliff'

24 August 2010

US pharma giant Merck & Co (MRK: NY) Friday sued Impax Laboratories (Nasdaq: IPXL) in the federal court in New Jersey in order to prevent the company from selling a generic version of its cholesterol-lowering drug Vytorin (ezetimibe/simvastatin), before the expiry of the patent which is due in 2017. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Merck has also sued US generics firm Mylan and global copy drugs giant Israel-based Teva Pharmaceutical Industries in connection with the filing of Abbreviated New Drug Applications with the Food and Drug Administration seeking approval to market a copy of Vytorin.

The move follows Impax' confirmation that it has initiated a challenge of patents listed by MSP Singapore (the unit of Merck which holds the patent) in connection with Vytorin 10mg/80mg.

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