Natco Pharma loses patent litigation case over anti-cancer drug Ibrutinib in US

In the year 2018, NATCO and Alvogen filed an Abbreviated New Drug Application (ANDA) with PIV certification for the generic version of the product, anti-cancer medicine Imbruvica.

However, Natco Pharma Limited in its recent filing announced that a US District Court has issued a decision in favour of Pharmacyclics, a subsidiary of AbbVie, the brand owner of Imbruvica in a PIV litigation involving the product.

The generic version of the brand Imbruvica is Ibrutinib, which is an orally bioavailable, small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity.

Upon oral administration, Ibrutinib binds to and inhibits BTK function irreversibly, blocking both B-cell activation and B-cell-mediated signaling. The proliferation of malignant B cells that overexpress BTK is inhibited as a result of this.

BTK, a member of the src-related BTK/Tec family of cytoplasmic tyrosine kinases, is required for B cell receptor signaling, plays a key role in B-cell maturation, and is overexpressed in a number of B-cell malignancies. The expression of BTK in tumor cells is also associated with increased proliferation and survival. The said drug is categorized as a targeted covalent medication with a promising action against B cell malignancies

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Pharmacyclics Inc developed ibrutinib, which was approved by the FDA in November 2013 for the treatment of mantle cell lymphoma. Ibrutinib was later approved in February 2014 for the treatment of chronic lymphocytic leukaemia and Waldenström's Macroglobulinemia patients. The European Medicines Agency had also approved ibrutinib for the treatment of chronic lymphocytic leukaemia and mantle cell lymphoma. In August 2017, ibrutinib was approved for the treatment of chronic graft versus host disease.

In line with the US District Court verdict, Natco Pharma stated, "NATCO and its marketing partner in the US for the product, Alvogen Pine Brook LLC, USA, shall review the judgement and evaluate all options to appeal the judgement. We believe that we have a strong case and will continue to defend it vigorously. "

Also Read: Natco Pharma gets USFDA nod for Ibrutinib tablets in US