Shire plc has received a Paragraph IV notice letter from Corepharma LLC advising of the filing of an Abbreviated New Drug Application (ANDA) for its carbamazepine extended release products, generic versions of Shire's Carbatrol. The notice letter is directed to 100 mg, 200 mg and 300 mg strength products. Shire is currently reviewing the details of Corepharma's Paragraph IV notice letter.
Shire has previously announced that it received a notice letter from Nostrum Pharmaceuticals, Inc. regarding its ANDA for a 300 mg strength generic Carbatrol product. Shire has filed a lawsuit against Nostrum regarding this notice letter and the litigation is pending in the District of New Jersey.
Carbatrol is an important product for the treatment of epilepsy and trigeminal neuralgia, and is protected by two patents, US Patent No. 5,326,570 and US Patent No. 5,912,013.