Ranbaxy settles spat with Takeda over Actos

Ranbaxy Labs has resolved its patent litigation with Takeda Pharma related to its generic version of Actos.

As per the agreement, Takeda granted Ranbaxy a non-exclusive royalty free licence to its US patents covering Actos, and Ranbaxy can launch its generic on August 17, 2012, or even earlier, under certain circumstances.

“This agreement will allow Ranbaxy to bring to diabetics, a generic alternative in this important therapeutic area,” Jim Meehan, vice-president, sales and distribution for Ranbaxy Pharmaceuticals Inc, said.

Actos (generic name pioglitazone) used as an oral medication for type II diabetes had sales of $3.4 billion in 2009, according to IMS Health.

Actos received a boost of sorts last month when US Senators said that Actos’ rival Avandia (rosiglitazone) by GSK, which belongs to the same glitazone class of diabetes drugs, confers an increased heart risk as compared to Actos, and does not offer
any unique health benefits over Actos.

With the FDA now reviewing Avandia to assess heart risks, several medical practioners are switching over to Actos. The basic patent for the drug expires in January 2011, and other patents covering methods of treatment using Actos and certain compositions that include Actos, expire in 2016.

Industry experts say the settlement would not mean much to Ranbaxy in terms of revenues. “There would be no significant upsides for Ranbaxy from this product,” says Sarabjit Kour Nangra, vice-president - research, Angel Broking.

Various analysts and industry professionals feel Ranbaxy could earn about $100-150 million on an annualisedbasis on this drug.

A reason for this may be that leading generic drug makers such as Watson Pharma, Alphapharm, Teva, and Mylan have received tentative approval for generic Actos.

“So the competition will be fierce and Teva, Mylan are strong generic competitors,” says Ranjit Kapadia, vice president, institutional research, HDFC Securities.

In fact last week, Watson Pharma reached a similar agreement with Takeda over Actos, so Watson can launch its generic tablets on August 17, 2012, or earlier, like Ranbaxy.

The dispute dates back to 2003, when Takeda filed patent infringement actions against Mylan, Ranbaxy Laboratories and Watson.