Astellas files lawsuit against Nycomed

Japanese pharmaceutical company Astellas has filed a patent infringement lawsuit in the US against Nycomed in relation to Protopic (tacrolimus), an eczema medicated ointment.

The lawsuit has been filed as a result of Nycomed submitting an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for a generic version of Protopic – Astellas' 0.1 per cent tacrolimus ointment.

Astellas filed the patent infringement action in the US District Court for the District of New Jersey on October 27, 2010. Astellas is petitioning for Nycomed's ANDA not to be approved before the expiration of two patents held by Astellas in relation to Protopic.

Protopic ointment is indicated for the treatment of moderate to severe eczema and has been approved for use in the US since the end of 2000. Protpoic is available in two dosage strengths – 0.1 per cent and 0.03 per cent. It is recommended that children aged between two and 15 years should only receive the 0.03 per cent strength of the ointment.