Health and Medical Information

Clarinex marketed by a pharmaceutical company Schering-Plough has got a number of generic competitors, especially made by such Indian companies as Ranbaxy and Dr. Reddy’s.

Due to expiration of the Clarinex patent, Ranbaxy, the second-biggest pharmaceutical company in India, applied for manufacturing a generic version of the drug. However, two companies, Ranbaxy and Schering-Plough, came to an agreement to postpone generic Clarinex sales until 2020, when the patent will expire. If another company is able to challenge the patent’s validity by that time, the world will see the generic Clarinex earlier.

Clarinex was first approved by FDA in 2001 right after the expiration of the Claritin patent. Claritin which went OTC in the USA is another antihistamine drug manufactured by Schering-Plough.

In 2006, Schering-Plough had some 12 lawsuits with generic manufactures of Clarinex, including the Indian biggest pharmaceutical company Dr. Reddy’s Laboratories Ltd., to stop the sales of generic version of Clarinex.

A number of Americans suffering from allergy reaches 50 million and the number of the work days lost due to the illness is around 100 million per year. Thus, Schering-Plough is seeking a solution to combine the best features in a new anti-allergy medication.

Meanwhile, Schering-Plough goes on with manufacturing Clarinex in different forms. For instance, recently FDA approved Clarinex in syrup for seasonal outdoor allergy in children aged 2 and older and for indoor allergies and urticaria in infants aged 6 months and older. Clarinex syrup is the only antihistamine drug that does not cause sedative effective approved for use in children and infants. The drug was approved basing on the outcomes of a study that involved more than 240 children of different age (6 months to 11 years of age). The trials showed that children taking Clarinex had the same side effects as children taking placebo, thus the syrup was considered as safe.