Delhi-based Morepen Laboratories is eyeing on the increased exports of Loratadine, an antihistamine, for boosting its business prospects in the coming months. The company has started receiving fresh orders from bulk drug companies like Genpharm, and is expecting a business of more than $20 million in the current calendar year.
Morepen had since January, carried out $15 million worth exports of Loratadine to international market. This was part of an arrangement with Geneva Pharma, the first ANDA filer as the sole supplier for Loratadine. Geneva had six-month exclusivity on marketing Loratadine, which came to an end recently. The company feels that the prices of Loratadine have stabilized in international market and have not come down in spite of end of the exclusivity period. It pins hope on the fresh orders now.
Loratadine had gone off-patent in December and has become the over the counter (OTC) product in December 2002, resulting in huge surge in demand for the drug.
Morepen has the capacity to produce 24 tonnes of Loratadine per annum. The manufacturing facility of the company is the only US Food and Drug Administration (USFDA) approved API facility in India and the largest generic facility for Loratadine in the world. The company is already making the drug in the domestic market from the basic stage and since there are no other USFDA approved plants for Loratadine in India, there is virtually nil competition. Morepen is already exporting bulk Loratadine to a number of non-patented markets and has around 28 registrations in European market.
According to an official release, Morepen is getting ready to file the ANDA for Loratadine and Atorvastatin in the US market. The company had already launched Ranitidine, an anti-ulcer drug, in US market through MorepenMax, a joint venture company between Morepen and Florida based DrugMax. Atorvastatin is the no 1 drug worldover and has a market size of more than US$ 10 billion. Morepen has a process patent for new and improved process for preparation of amorphous form of Atorvastatin Calcium.