Morepen files atorvastatin patent in 33 countries

EPP News Bureau - Delhi

Morepen Laboratories Limited has filed patent for new polymorphic form VI of atorvastatin calcium, a cholesterol-lowering drug, in 33 countries including US, Canada and other European countries.

Atorvastatin calcium (Lipitor) is the largest selling drug in the world today with a market size of US $10 billion equivalent to Rs 45, 000 crores approximately.

Morepen is in the process of finalising tie-ups with US generic companies for launch of this product in the US generic market. The company hopes to capture a market size of 15 - 20 per cent for this drug in the post patent regime.

Morepen received an approval for atorvastatin under the Patent Cooperation Treaty (PCT) last year and the same was published by World Intellectual Property Organisation (WIPO).

Statins are growing at a phenomenal rate globally with current collective market size of close to USD 20 billion. Atorvastatin, fluvastatin and simvastatin are used in the treatment of hyperlipidaemia 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.

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

The patent filings are in line with Morepen’s stated objectives of being the leading supplier of APIs in global regulated markets.

Morepen is a preferred generic manufacturer of bulk drugs internationally and the largest generic manufacturer of Loratadine in the world.