Sepracor lawsuit might block drug
Rivals planning generic version
By Susan Decker BLOOMBERG NEWS
MARLBORO— Sepracor Inc. sued rival drug makers Dr. Reddy's Laboratories Ltd. and Mylan Inc. to block them from selling a generic version of the allergy pill Clarinex.
Dr. Reddy's and Mylan are seeking U.S. Food and Drug Administration approval to sell generic versions of the medicine. Sepracor contends the generic drugs will infringe its patent rights and is seeking to block approval until two Sepracor patents expire in 2014.
Clarinex, which first received regulatory approval in 2001, is the successor to the allergy pill Claritin, a medicine now available in the U.S. without a prescription. Schering-Plough Corp. sells the drugs, and Sepracor, based in Marlboro, receives patent royalties on the sales.
"The lawsuit is without merit and we intend to defend ourselves vigorously," Lee Banks, vice president of intellectual property management for Dr. Reddy's in Hyderabad, India, said in a phone interview today. "It was totally expected and we were just waiting for it."
Sepracor and the University of Massachusetts, which co-owns the patents, filed the lawsuits last week in federal court in Trenton, N.J.
Kris King, spokeswoman for Canonsburg, Pa.-based Mylan, didn't immediately return a message seeking comment.
Last month, Sepracor sued Orchid Chemicals & Pharmaceuticals Ltd. and Sun Pharmaceutical Industries Ltd. over their applications to sell generic Clarinex.
Sepracor reported $12.5 million in second-quarter royalties from the sale of Clarinex and the Sanofi-Aventis allergy pill Allegra. Schering-Plough reported $625 million in sales of Clarinex during the first nine months of the year. |
