S-P's Claritin approved in Japan

Schering-Plough's non-sedating antihistamine Claritin (loratadine) 10mgtablet has been approved in Japan as a prescription product for the treatment of allergic rhinitis, chronic idopathic urticaria (hives of unknown cause) and itching associated with skin diseases in adults and children over 15. Claritin will be co-marketed by local subsidiary Schering-Plough KK and Shionogi & Co, and will be launched once it has received pricing approval.

The Japanese approval grants Claritin six years of data exclusivity. During this period, any competitor wishing to introduce a generic version of the drug would be required to submit an application to the Ministry of Health, Labor and Welfare that contains data from its own clinical trials.

It is estimated in an S-P press release that 15 million people in Japan are affected by allergic rhinitis, and the market for prescription antihistamines in the country is forecast to exceed $1 billion in the near future.