Aurobindo faces 3 cases in US for patent breach

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Three multinational pharma companies – Hospira, Kowa and the Medicines Company — have dragged Aurobindo Pharma to court over the latter’s plans to make copycat versions of their branded drugs even before patent expiry.

Hospira and Orion Corporation together filed a case against Aurobindo in the district court of Dela-ware on April 18, claiming that the Indian firm’s potential drug replicates the branded version of Precedex, for which Hospira holds patent No. 867.

The Medicines Company has filed a patent infringement suit as the Hyderabad-based firm prepares ground to make and sell a version of Angiomax, a branded drug used as an anti-coagulant after a coronary angioplasty.

The Medicines Company own two patents – 727 and 343 for bivalirudin – the content of the drug. Aurobindo had submitted a new drug application with the US Food and Drug Administration under abbreviated new drug application or ANDA No. 205,962.

Kowa Pharamceuticals and Nissan Chemical Industries have gone to the court against alleged bid by Aurobindo to make a generic version of their Livalo brand, for which they hold patent No. 336.

Kowa has sought “a permanent injunction restraining and enjoining against any infringement by defendants of the Livalo patents, through the commercial manufacture, use, sale, offer for sale or import into the US of Aurobindo’s pitavastatin drug product or any drug product containing it.”

Livalo is an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Kowa is also suing Zydus in a , Pharmaceuticals case on the same drug.

Hospira filed the petition in the US district court of Delaware. The drug is used for the sedation of initially intubated.

Indian copycat drugmakers, whose business thrives on making low-cost generic medicines, constantly face such cases. The launch of these products would depend largely on approvals from the US FDA.

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