Schering-Plough K.K., the Schering-Plough Corporation's subsidiary in Japan, has received approval to market the nonsedating antihistamine Claritin (loratadine) 10 mg Tablets as a prescription product for the treatment of allergic rhinitis (AR), chronic idiopathic urticaria (CIU), or hives of unknown cause, and itching associated with skin diseases in adults and children 15 years of age and above from Japan's Ministry of Health, Labor and Welfare (MHLW). Claritin, which will be co-marketed in Japan with Shionogi & Co. Ltd., will be launched upon receiving pricing approval.

With MHLW approval, Claritin is entitled to six years of data exclusivity, during which time any competitor wishing to introduce a generic version of Claritin would be required to submit an application to MHLW that contains data from their own clinical trials.

Allergic rhinitis is estimated to affect some 15 million people in Japan. The market for prescription antihistamines in Japan is estimated to exceed $1 billion.

Affecting an estimated 15 to 25 per cent of people at least once in their lives, urticaria is a reaction to a variety of substances, including food, drugs and topical agents, and characterized by an eruption of itchy, swollen lesions on the skin. An estimated 25 per cent of urticaria patients develop CIU, which is defined as a case that lasts for a period of at least six weeks and has no identifiable cause. More than 40 per cent of prescription antihistamine use in Japan can be attributed to CIU and itching associated with skin diseases such as eczema.