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9 August 2016Americas

Hi-Tech Pharmacal sued over Ulesfia generic

Shionogi and Concordia Pharmaceuticals sued Hi-Tech Pharmacal yesterday for allegedly infringing patents centring on the drug Ulesfia (benzyl alcohol), an anti-parasite medication.

The dispute arose after Hi-Tech applied for an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration seeking approval to manufac ture a generic version of the drug prior to the expiration dates of the patents involved.

The patents in suit are US number numbers: 6,793,931 and 7,294,342.

The complaint was filed at the US District Court for the District of Delaware.

Shionogi, which has a licence to market Ulesfia from Concordia, received a notice of Hi-Tech’s ANDA certification in June in which Hi-Tech claimed that the patents were invalid and would therefore not be infringed by the generic.

Shionogi and Concordia have asked the court for an injunction preventing Hi-Tech from manufacturing the generic drug, and have asked that they be awarded damages including costs of the lawsuit if Hi-Tech decides to go through with the launch.

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