Indian simvastatin makers line up atorva products

Indian generic companies are realigning strategies in the US statin market with atorvastatin, the top selling drug in the category, going off-patent.

Statins are a class of drugs used to lower blood cholesterol level.

The full genericisation of atorvastatin is set to hit revenues of simvastatin, another statin, which Indian drug makers operating in the space currently make.

Indian players, including Aurobindo Pharma and Dr Reddy’s, are now lining up products in the atorva space as simvastatin volumes and price are seen shrinking considerably.

“The genericisation of atorva can bring in significant changes in the statin market of the US with the market leader simvastatin gradually losing out its top position to atorva,” Chirag Dagli and Gagan Borana, analysts with ICICI Securities, said in their report last month.

Lupin is the market leader in the US statin market with a volume share of 26%, while Dr Reddy’s and Aurobindo Pharma are the key players.

“Any drug going off-patent will definitely show its impact on the existing generic of the same category. There is bound to be price erosion in both the existing generic and the new generic. Aurobindo has already filed the documents for atorva with the US regulator. The approvals are expected sometime next year,” a source associated with Aurobindo told DNA Money.

He, however, said the price erosion would not alone decide the statin market shares. “Reliability and quality of the product and supplies would make the difference. In the case of simvastatin, the supplies are adequate and the product has established itself to be reliable,” he said.

Before the full genericisation of simvastatin in June 2006, atorvastatin was the market leader in the US statin market with a 57% volume share and simvastatin had a share of about 22%. Following genericisation of simvastatin, the price erosion has encouraged the patient preference too to change in favour of simvastatin. Currently, atorvastatin and simvastatin account for 80% of the statins market.

“The equation once again stands to change with the genericisation of atorva. It will significantly bring down the difference between the costs of treatment with atorva and we expect atorva sales to grow at the cost of simva as the former is a better statin,” said Dagli and Borana.

However, industry sources said that the complexity in manufacturing atorvastatin would be an entry barrier for many at this point and help the simva market.

 “We are also working on atorvastatin and the product is progressing well,” a Dr Reddy’s spokesman said without willing to disclose timeframe for the launch.

Analysts see atorva gaining 4% market share after generisation, with most gains coming at the cost of simvastatin.

Sounding an alarm, the ICICI Securities analysts said, “We estimate atorva’s volume share in the US statin market to increase from 28% to about 40% over the next two years. Accordingly, we estimate simva’s market share to decrease from 49% to about 37%, leading to 12% decline in volumes annually.”

There are six players in the atorva market in the US and at least another two are expected to join shortly. Ranbaxy, which has the first-to-file opportunity, is expected to make the most of the off-patent opportunity.

 “The simvastatin players are bound to take a hit with the volumes dropping and the price eroding further. So, most of them have no option but to join the atorvastatin market. However, in the current conditions it is not easy for these new players in the atorva market to gain their share since the market has already been distributed and the price too has eroded significantly,” a pharma sector official said.