Delhi based Morepen Laboratories has filed a Drug Master File (DMF) for desloratdine in the US market. The drug, innovator brand Clarinex (Schering) of which is having a market of $700 million, is a metabolite of loratadine and is indicated as an anti-allergic drug with longer lasting relief as compared to loratadine.

Morepen has claimed to be the first company to file DMF in the US for desloratadine.

The filing of the DMF in the US for desloratadine is important for the company as it is expected to help them consolidate their hold on the loratadine active pharmaceutical ingredient (API) franchise in the US. While loratadine has been switched to over-the-counter (OTC) drug in the US, desloratadine continues to be a prescription drug, which is having higher realisation in the market.

Morepen is a preferred generic manufacturer of bulk drugs internationally and the largest generic manufacturer of loratadine in the world. With a market capitalization of more than US$ 50 million and three high-tech plants at Himachal, Morepen exports to over 50 countries, including the highly regulated markets of the US, Western Europe and Canada.