Ranbaxy Laboratories may soon get over the splitting headache it has had since failing to capitalise on the first to file (FTF) opportunity for GSK’s migraine drug Imitrex a year ago.
The Gurgaon-based drugmaker, owned by Japan’s Daiichi Sankyo, is confident of monetising three other billion-dollar opportunities coming right up —- Flomax, Lipitor and Nexium.
The company has the FTF status on all the three drugs, which gives it six-month sales exclusivity on each in the US. In other words, it would be the only company marketing the generic versions of these drugs during this period, other than the respective innovator company.
“We are confident about cashing in on these opportunities, like we did with Valtrex in November,” a top official said.
Valtrex (valacyclovir hydrochloride) is the $1.3 billion innovator drug of GlaxoSmithKline used in treatment of herpes. With the launch of its generic version in the US, analysts expect sales of $160-200 million for Ranbaxy during the exclusivity period.
The US is a key market for Ranbaxy, and accounted for about 24% of its sales last fiscal.
Flomax, Lipitor and Nexium are the innovator drugs of Yamanouchi (now a part of Astellas Pharma), Pfizer, and AstraZeneca, respectively. As per IMS Health estimates, the drugs recorded sales of $1.2 billion, $13.65 billion and $7.8 billion, respectively in 2008.
The launch date for generic Flomax (tamsulosin), which is used for treating the enlargement of the prostrate gland in men), is March 2010.
Likewise, Ranbaxy gets to market generic Lipitor (atorvastatin), the world’s largest selling drug, used for cholesterol reduction, from November 30, 2011.
As for generic Nexium, used for treating heartburn, Ranbaxy can start selling the drug from May 27, 2014.
Sales of these drugs, especially during the 180-day exclusivity, will be crucial for the company.
Analysts expect Ranbaxy to garner about $150 million through generic Flomax during the exclusivity.
From Lipitor, it could make $2 billion during the exclusivity on a conservative basis, feels Sarabjit Kour Nangra, vice-president - research at Angel Broking.
On its part, Nexium is expected to fetch about $1.5 billion, including exclusivity period sales, gains from supplies of the active pharmaceutical ingredient in the drug —-esomeprazole magnesium —- to AstraZeneca from May 2009 and gains from selling some Nexium from May 2010 as per other settlements.
However, the US FDA issues bugging the company’s Paonta Sahib and Dewas facilities are yet unresolved. This could force it to launch the generics from its Ohm facility in the US, like it did with Valtrex.
“If the launch is from Ohm facility, then the cost of production will be more than it is in India,” said Ranjit Kapadia, vice-president, institutional research, at HDFC Securities.
Comments