Dr Reddy's sees negligible effect of FDA curbs on simvastatin

Dr Reddy’s Laboratories sees the impact of fresh regulations by the US Foods and Drug Administration (FDA) on prescription of 80 mg dose of cholesterol lowering statin drug simvastatin due to risk of muscle injury to be negligible on overall revenues.
Several other Indian pharma players may be affected more by the FDA move.

The FDA has recommended that only those patients who have been on the 80 mg version of the drug for a year or more without consequence should continue to take it.
If physicians find that 40 mg is not adequately controlling a patient’s LDL levels, the FDA says a different statin should be employed.

The current market size of Simvastatin for a variety of strengths ranging from 5 mg to 80 mg tablets is estimated to be at about $468 million.

The 80 mg strength, of the total market, has a share of about 15% valued at about $70 million.

“Dr Reddy’s is aware of the recent warning notice issued by the FDA. However, we are not in a position to provide specific comments regarding the FDA’s stance regarding Simvastatin 80 mg.  While we do not provide product-specific revenue figures, we can confirm that the overall impact of the simvastatin 80 mg strength will be negligible to our overall revenue,” a Dr Reddy’s spokesman told DNA Money.

Market estimates peg the share of Dr Reddy’s in the US simvastatin 80 mg market at about 10%, or about `31.5 crore in value terms. Lupin is estimated to be the market leader with a share of about 31%.

Total annualised market sales for Simvastatin were $4.8 billion prior to the patent expiry in 2006, of which $4.2 billion were for the 5 mg, 10 mg, 20 mg and 40 mg tablets.