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RANBAXY Laboratories has announced that it has settled a patent dispute with Takeda Pharmaceutical allowing the Gurgaon-based drugmaker to launch its generic tablets of Takeda’s diabetes drug Actos in 15 mg, 30 mg and 45 mg dosages in the US by August 2012.

 â€œUnder terms of the agreement, Takeda granted Ranbaxy a non-exclusive royalty free license to its US patents covering Actos. Ranbaxy has certainty in the launch of its generic equivalent formulation of Actos on August 17, 2012, or earlier under certain circumstances,” it said in a media release.

The company did not elaborate the circumstances or for which patent number the settlement was.

Actos (chemical name Pioglitazone Hydrochloride) has annual sales of $3.4 billion in the US, according to research firm IMS Health. Afew days back, US-based Watson also announced it also agreed to a settlement with Takeda allowing the American drugmaker to sell its generic version of Actos on the same date as Ranbaxy’s scheduled launch date.

In October 2003, Takeda had sued Ranbaxy, Watson Pharmaceuticals Inc and Mylan Laboratories to block their low-cost versions of its drug alleging the three companies infringed on its US patents for Actos.

Analysts says the financial upside would depend on the multiple factors such as number of companies who will share the exclusivity and the launch date.
“Since it is nonexclusive settlement, other generic players can also launch their products. Ranbaxy could get a significant revenue upside but putting a number would be on several assumptions,” a Mumbai-based analyst with a foreign brokerage firm said.

Actos is protected by multiple patents in the US. While the main patent expires in January 2011, others are valid till 2016. As per the Takeda release, two companies Alphapharm and Mylan had failed to invalidate its US patent number 777 that expires in 2011.

Under US patent laws, the first generic drugmaker to challenge the patent of an innovator drug is given 180 days marketing exclusivity as an incentive for advancing the launch of low-cost drugs to consumers.

In this case, at least Mylan and Watson can also share the exclusivity with Ranbaxy.

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