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Morepen files patents for cholesterol drug

Our Bureau

NEW DELHI, May 21

MOREPEN Laboratories Ltd has filed an international process and product patent for the drug, Fluvastatin Sodium.

Fluvastatin, according to the company's statement, is a cholesterol-lowering drug from the `statin' family and has an estimated market size of $500 million globally and that is growing at the rate of 25 per cent.

This is the tenth patent filed by Morepen and the fourth in a period of less than a year. Since the patent expiry of the product is by end of this 2003-04, a number of Canadian and European customers are working with Morepen to launch the generic version after the patent expiry.

Morepen already has a process patent in the statin family for amorphous and polymorph form of Atorvastatin, the number one drug globally and Fluvastatin comes second.

Speaking on the development, Mr Sushil Suri, CMD, Morepen Labs, said "this will give us a quick entry into statins market resulting in good revenues for the company in near future owing to an early patent expiry, thus contributing to the bottomline of the company."

According to the company, this new polymorph (crystalline) form of the drug developed by Morepen is an improved version of fluvastatin sodium, which bestows greater yield of highly pure form that has very miniscule values of left-over solvents and degradation products.

Development of non-infringing processes and new polymorphs with the patent protection will provide Morepen a competitive edge to capture major generic market share.

Sandoz of the US is the innovator of the product and the patent expires in 2003-2004 in Europe and Canada.

The drug is widely used in the treatment of hyperlepidemia and hypercholesterolemia.

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