The Rs. 530-crore Morepen Laboratories has filed an international patent under the Patent Cooperation Treaty (PCT) for manufacturing process of Desloratadine, the $500 million drug meant for treatment of allergy, cough and cold.

The company is further working to file the Drug Master File (DMF) for the drug in the US market in order to obtain the US Food and Drug Administration (USFDA) approval.

The company has also launched the generic version of the drug in the domestic market and is marketing the drug under the brand name `DesNova'.

Morepen has developed an efficient and much improved process to manufacture Desloratadine from Loratadine for which the PCT application has been filed.

The global market for Desloratadine is estimated to be around $ 500 million and is growing fast. The international patent for Desloratadine is held by Schering Plough, which is marketing the drug in the US market under the brand name `Clarinex'. The patent for the drug in the US is slated to expire in April 2004.

Speaking on the occasion, Mr. Sushil Suri, Chairman and Managing Director, Morepen Laboratories said, "Entry into the Desloratadine market gives us access to the highly regulated US prescription segment, which we missed because of the Over the Counter (OTC) switch. It will further help us to be around whether it is generic OTC or prescription segment."

Desloratadine is a metabolite of Loratadine possessing anti-histamaminic activity, which is mainly used for treatment of allergy, cough and cold etc. The drug is used for treatment of allergy symptoms caused by perennial indoor and seasonal outdoor allergens and chronic idiopathic urticaria (CIU) with non-sedating relief for a full 24 hours.

Schering-Plough Corporation's Clarinex 5 mg Reditabs, has already been approved by the US Food and Drug Administration. In fact European Commission of the European Union (EU) has also granted marketing authorization for a syrup and tablet formulation of the non-sedating antihistamine Desloratadine as a once-daily treatment.

Meanwhile, Morepen has already started exporting bulk Loratadine to the US market, whose patent expired in December 2002. Morepen has an exclusive arrangement with Geneva Pharma (the Generic arm of Novartis AG) to supply bulk Loratadine to it.

Further, Geneva has been granted a 180-day marketing exclusivity to market the drug in the US market in January this year. During the period of exclusivity, Morepen aims to garner an additional turnover of around $20 million (Rs. 100 crore) through supplies to Geneva.

Mr. Suri added, "We will supply bulk Loratadine for four or five months but Geneva will be filling in a pipeline for nine months to the tune of Rs. 100 crore by July this year, as the exclusivity ends on July 21. We have already started receiving orders. It's a 60-day cycle, and the main shipment has already started from March and a major part of the order will be shipped during the months of March and April this year."

Apart from Geneva Pharma, the company is also supplying bulk Loratadine to companies like McNeal, Perigo etc.

Loratadine is already a block-buster drug with annual revenues of around $3.2 billion and the innovator, Schering Plough markets its drug under the brand name Claritin. Loratadine is approved for seasonal allergic rhinitis- a condition that causes runny nose, nasal congestion, sneezing and itchy nose, throat, eyes and ears.