Cogencis, Thursday, May 14

--Teva seeks ban on US sale of Aurobindo Pharma's Bendeka generic

By Narayana Krishna

HYDERABAD - Teva Pharmaceuticals International GMBH and Eagles Pharmaceuticals have together filed a case in the US against Aurobindo Pharma Ltd and its subsidiaries for alleged patent infringement of its cancer drug Bendeka, according to a court document reviewed by Cogencis.

The patent infringement petition was filed at a US District Court for the District of Delaware.

Aurobindo Pharma's US arm filed an abbreviated new drug application with the US Food and Drug Administration, seeking approval for Bendeka generics, used for treatment of patients with chronic lymphocytic leukemia.

On Apr 6, Aurobindo Pharma notified about its Bendeka generic filing with Para-IV tag with US regulator, the document showed.

"In an exchange of correspondence, counsel for Teva and counsel for Aurobindo discussed the terms of Teva's Request for Confidential Access. The parties did not agree on terms under which Teva could review," Teva Pharma said in its petition.

Aurobindo Pharma refused to produce other internal documents and materials relevant to infringement, the document showed.

Bendeka and along with another drug Treanda had clocked combined sales of $496 mln in 2019 in North America, reports said.

Shares of Aurobindo Pharma slumped today after Cogencis reported the news. At 1501 IST, the company's shares traded at 664.35 rupees, down 1.7%, on the National Stock Exchange.

In the lawsuit, Teva Pharmaceuticals claimed Aurobindo Pharma's abbreviated new drug application to the US Food and Drug Administration for generic of Bendeka violates its patents that it has licenced from Eagles Pharmaceuticals.

Teva Pharmaceuticals sought a preliminary and permanent injunction against the sale of the generic version of the drug in the US by Aurobindo Pharma.

Earlier, Teva Pharmaceuticals had won a similar patent violation case against Mylan's generic version of the drug.  End

US$1 = 75.56 rupees

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

Edited by Akul Nishant Akhoury

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