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This follows the settlement of the patent dispute with Japanese pharma major Takeda over a generic version of the drug. IMS Health, a global pharma research firm, put Actos global sales last year at $3.4 billion, of which the US market accounts for $1 billion.
Under the terms of the agreement, Takeda granted Ranbaxy, which is majority owned by Japan’s Daiichi Sankyo, a non-exclusive royalty-free licence to its US patents covering Actos. This would allow Ranbaxy to launch its generic version of Actos on August 17, 2012, or earlier under certain circumstances, a company statement said. It did not specify the circumstances under which the drug may be launched earlier than 2012.
Pharma analysts were not excited by the development.
Ranjit Kapadia of Mumbai-based HDFC Securities said, “There is no information on the first-to-file (FTF) clause providing for 180-day marketing exclusivity period to the company.”
FTFs are applications filed with the US Food and Drugs Administration (FDA) for approval of generic versions of branded drugs whose patents are about to expire. If passed, the company gets 180 days of exclusive marketing rights.
On the potential top line gain for Ranbaxy, he said, “It is difficult to predict but would depend on how other companies including Mylan and Teva, which too had been granted the generic approval compete with Ranbaxy.”
It is a blockbuster drug but sales would get fragmented if several players get to sell it, he added.
Sapna Jhawar of Mumbai-based Sharekhan said that the patent settlement was a major plus for India’s largest pharmaceutical company by sales, Ranbaxy.
“There are not too many blockbuster drugs attracting that kind of sales and the scenario is unlikely to change in the near future.”
She agreed that the presence of other players would have an effect.
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