Eli Lilly sues Sun Pharma over Cymbalta patent

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Mumbai: US drug major Eli Lilly, continuing its fight against the generic launch of its second-largest selling drug, Cymbalta, sued Sun Pharma on December 4. This was in response to the Indian drug major filing an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA), seeking to launch a generic version of the anti-depressant.

Last month, Lilly had sued Indian drug majors Wockhardt, Aurobindo Pharma and Lupin for alleged infringement of its patent for Cymbalta (duloxetine hydrochloride), which expires in 2013.

Cymbalta’s sales were worth $2.1 billion in 2007, next only to Lilly’s anti-psychotic drug Zyprexa. Sales for Zyprexa were worth $4.76 billion during the year. Cymbalta, used to treat anxiety disorders, achieved sales worth $716 million during the third quarter of this fiscal, registering a 40% growth.

Earlier, apart from Indian majors, Lilly had sued other generic players such as Cobalt Laboratories, Impax Laboratories and Sandoz Inc.

When contacted, a Sun Pharma spokesperson refused to comment on the issue.

Incidentally, the patent for Cymbalta, launched in 2004, expires along with the patents for Lilly’s cancer drug Gemzar and insulin Humalog in 2013. Regulators have approved Cymbalta to treat major depressive disorders, diabetic peripheral neuropathic pain, generalised anxiety disorders and fibromyalgia.

Last month, Sun Pharma was sued by Schering Corporation for alleged infringement of the latter’s patent for its anti-allergic drug Clarinex. Sun Pharma was also sued by Orion Corporation, following its application for a generic version of Orion’s Comtan, used for treating Parkinson’s disease.

Sun Pharma is awaiting about 96 ANDA approvals in all from the US FDA. While the company’s US subsidiary Caraco has filed 19 of the applications, the remaining have been filed by Sun Pharma.