Lupin, Natco team up for generic launch of Shire's `Fosrenol'

Lupin Ltd and Natco today announced an alliance to jointly commercialise generic equivalents of Shire plc's `Fosrenol' (lanthanum carbonate) tablets. Shire had filed a lawsuit against Natco for infringement of two patents for Fosrenol in response to an ANDA (abbreviated new drug application) filing by Natco seeking US FDA approval to market and sell generic versions of Shire's 500 mg, 750 mg, and 1 g of the Fosrenol tablets.

Fosrenol tablets are used to treat chronic kidney ailments and India is a key market for the product.

Natco and Lupin said they are amongst the first to file ANDA for Fosrenol,  which would likely lead to 180 days exclusivity. Fosrenol had sales of $108 million as of December 2008.

''The alliance creates synergies that will enable portfolio expansion and contribute to consolidating our presence in the US markets. Lupin's proven IP management capabilities, marketing reach and expertise coupled with Natco's solid development and manufacturing abilities make for a great combination,'' Nilesh Gupta, group president and executive director of Lupin Limited, said.

''Our alliance brings together a strong philosophy of working together to maximise opportunities in an increasingly competitive generic business. We are very happy to be associated with Lupin given their intellectual property management competencies and market strengths in the US,'' Rajeev Nannapaneni, chief operating officer of Natco Pharma, said.

Mumbai-based Lupin produces a wide range of both generic and branded formulations and APIs for the developed and developing markets. The company has secured global leadership position in anti-TB and cephalosporins and has a significant presence in the areas of cardiovascular, diabetology, asthma and NSAIDs.

For the financial year ended March 2008, Lupin reported revenues of  Rs2,773 crore ($694 million) and profit after tax of Rs408 crore ($102 million).