Morepen Labs Limited filed International process and product patent for the drug Fluvastatin Sodium. This is the tenth patent filed by Morepen and the fourth in a period of less than a year, stated a company release.
Fluvastatin is cholesterol-lowering drug and belongs to the Statin family and has an estimated market size of US $ 500 million globally that is growing at the rate of 25 per cent. Morepen is the only generic manufacturer of this product worldwide. Since the patent expiry of the product is by end of this year, a number of Canadian & 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 no 1 drug globally and Fluvastatin is the second one, it said.
Speaking on the development Sushil Suri, CMD Morepen Labs said, "Morepen is the only player of Fluvastatin. This block- buster molecule will give us 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 bottom-line of 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 minuscule values of left over solvents and degradation products. The process ensures speed and consistency of production that is vital for improving the commercial viability of manufacturing the product. Development of non-infringing processes and new polymorphs with patent protection will provide Morepen a competitive edge to capture major generic market share. Sandoz of USA 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. The high order of efficacy and safety has made Fluvastatin a popular and prescribed product in the US, Europe and Canada. The company already has Technical package and is in the process of preparing for DMF to see the product sail through easily, both in regulated and non-regulated markets. Morepen has already started supplying the product to Latin American countries and have tied up with major European and Middles East Pharma Companies
The other patents granted to or filed by Morepen are for Atorvastatin Calcium -for new and improved process for the preparation of Atorvastatin calcium amorphous, Atorvastatin Calcium - for a novel process for the preparation of new polymorph of Atorvastatin calcium, Loratadine - for an improved process for the production of Loratadine and Desloratadine for improved process. In the area of formulation, Morepen has filed PCTs for method of preparation of garlic ointment for topical use in skin infection and Cotrimoxazole for method of preparation of antibacterial gel.