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US court rejects Natco Pharma partner’s appeal in patent litigation

US court rejects Natco Pharma partner’s appeal in patent litigation

US court rejects Natco Pharma partner’s appeal in patent litigation
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By CNBCTV18.com Nov 16, 2022 1:21:19 PM IST (Published)

The litigation is related to the anti-cancer drug Imbruvica, for which Chicago-based AbbVie's Pharmacyclics LLC holds the patent rights.

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Natco Pharma on Wednesday said that the Appeals Court in the United States has rejected its marketing partner Alvogen’s appeal in patent litigation related to the anti-cancer drug Imbruvica.


Alvogen’s appeal pertained to Ibrutinib Tablets of 140 mg, 280 mg, 420 mg, and 560 mg strength.

Ibrutinib is a generic version of the anti-cancer drug Imbruvica. Chicago-based AbbVie's Pharmacyclics LLC holds the patent rights for the Imbruvica brand.

In August last year, a US district court issued an order in favour of Pharmacyclics in a PIV litigation involving the product. It had upheld four patents related to the cancer drug Imbruvica.

In 2018, Natco and Alvogen filed an Abbreviated New Drug Application (ANDA) for a generic version of the product with the United States Food and Drug Administration (USFDA). Natco supplies the drug and Alvogen markets it in the US.

Natco Pharma and its partner Alvogen had received tentative approval for ANDA for Ibrutinib tablets 560mg, 420mg, 280mg, and 140mg strengths (generic for Imbruvica) from the USFDA.

The company and its co-development and marketing partner Alvogen Pine Brook LLC are assessing their options on the way forward.

The stock is currently trading at Rs 583.90, up 0.34 percent.

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