A US court has rejected the appeal of Natco Pharma’s marketing partner Alvogen’s appeal on Ibrutinib tablets, in a suit related to the proposed generic equivalents to Imbruvica tablets.
“Natco Pharma Ltd would like to update that the Appeals Court in the US has rejected its marketing partner Alvogen’s appeal on Ibrutinib Tablets of 140 mg, 280 mg, 420 mg and 560 mg strength (proposed generic equivalents to Imbruvica tablets),’‘ the Hyderabad-based company said in a release on Wednesday.
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Natco and its co-development and marketing partner, Alvogen Pine Brook LLC, USA, were assessing their options on the way forward, it added.
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Ibrutinib, sold under the brand name Imbruvica, among others, is indicated in the treatment of cancer. Natco and Alvogen filed an Abbreviated New Drug Application (ANDA) with Paragraph IV (PIV) certification for the generic version of the product according to USFDA norms in 2018, which got into litigation later.
Pharmacyclics, a subsidiary of Chicago-based AbbVie’s Pharmacyclics LLC, is the brand owner of Imbruvica.