Generic drugs online

Source: Business Standard

Date: 11-Apr-2009

Drug firms Lupin and Natco Pharma have allied to jointly commertadalafile generic equivalents of Fosrenol (lanthanum carbonate), the multinational drug maker Shire's chronic kidney disease drug (lanthanum carbonate), in the US. However, this will be possible only after 2012, due to patent laws.

According to the alliance, Lupin will take care of the marketing and litigation related to the copycat versions of the 500 mg, 750 mg, and 1g tablets, developed by Natco Pharma.

"The alliance creates synergy that will enable portfolio expansion and contribute to consolidating our presence in the US markets," said Nilesh Gupta, group president and executive director, Lupin.

"We are very happy to be associated with Lupin, given their intellectual property management competencies and market strengths in the US," said Rajeev Nannapaneni, COO, Natco Pharma.

The drug had annual sales of $108 million in the US in 2008, according to drug sales tracking agency IMS' data.

Analysts said the alliance was one of the first instances in which Indian generic companies team up to sell generic drugs in the US. Ranbaxy's alliance with Zenotech for selling cancer drugs is one such alliance.

Shire had sued Natco for alleged infringement of two patents for the drug, in response to an Abbreviated New Drug Application filing by Natco. Under US rules, when a generic company says it is challenging an innovator company patent, the latter has to sue the challenger within 45 days to block approval of the generic for 30 months. Sources said this period will expire by April 2012. However, two main patents on the drug are valid till 2018 and another till 2024.

Natco and Lupin believe that they are amongst the first to file, which would likely lead to 180 days exclusivity. According to rules, the first to file for a generic gets six months exclusive sales after patent expiry.