Morepen Laboratories Limited, going ahead with its US Generic marketing strategy has filed USDMF for New Polymorphic Form VI of Atorvastatin Calcium, a cholesterol-lowering drug, in the United States with USFDA. It is also in the process of submitting the same for the European markets.

Earlier it had filed a patent for this drug in US, Canada and 31 other European countries.

Atorvastatin Calcium (Lipitor) is the largest selling drug in the world today with a market size of US $ 9 Billion equivalent to Rs.40,000 Crores approximately.

Statins like Atorvastatin, Fluvastatin and Simvastatin are used in the treatment of hyperlipidemia and hypercholesterolemia. Morepen has the proprietary technology to manufacture highly pure and stable crystalline polymorphic Form VI and amorphous forms of these drugs and also has full DMF for the same.

Morepen is in the process of finalizing tie-ups with US & European Generic Companies for launch of this product in their respective markets. The company hopes to capture a market share of 15 – 20% in the post patent market.

The filing of DMF would give Morepen an immediate entry into the regulated markets of USA, Europe and Canada.