Morepen Labs Limited has developed a new process to manufacture Montelukast, a high value anti-asthmatic drug. The company recently filed an international process patent application also on the "improved method for the preparation of Montelukast acid and sodium salt thereof in amorphous form".
Montelukast, which has an US market size of US$ 1.24 billions growing at the rate of approximately 24%, is prescribed as single daily dose with an added advantage for pediatric use. This new non- infringing process is cost effective with high purity, low residual solvent contents and elevated yield, stated a company release.
Morepen has developed and filed PCT application on a novel process for the preparation of exceptionally pure Montelukast acid converted to a superior quality of Montelukast Sodium.
This is the seventh international patent filed by Morepen in less than two years.
This will also give Morepen an advantage to circumvent the patents of polymorphs which are crystalline forms and find its foot holds in regulated markets. Montelukast Sodium is an anti-asthmatic drug much in demand internationally, including regulatory markets as an effective treatment for asthma even in children. Morepen will be soon filing a DMF for the Montelukast Sodium.
Speaking on the development Sushil Suri, CMD, Morepen Labs said, "Innovation in pharmaceuticals is not possible without Research &Development. Montelukast Sodium is a unique treatment for asthma. Development of the non-infringing process yielding high purity product would lead to a demand globally hence, promising good revenues for the company in future."
The other patents granted to or filed by Morepen are for Fluvastatin Sodium, a 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%. Morepen is the only generic manufacture of this product worldwide. 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. 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.