Shire sues Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc.
Shire plc announced that its subsidiary Shire Laboratories Inc. has filed a lawsuit in the US District Court for the Eastern District of Pennsylvania against Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. ('Teva') for infringement of Shire Laboratories' US Patent Nos. 6,322,819 ('the '819 Patent') and 6,605,300 ('the '300 Patent').
The lawsuit results from an Abbreviated New Drug Application filed by Teva for generic versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALL XR®, Shire's Attention Deficit Hyperactivity Disorder medicine, pursuant to which Teva provided notice that it would seek to market its generic products before the expiration of the '819 and '300 Patents in 2018. The lawsuit alleges that all of Teva's generic strengths infringe the patents in suit. Pursuant to Hatch-Waxman legislation, there will be a 30-month stay with respect to Teva's proposed 25 mg dosage product.
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