Impax Laboratories Inc., which has recently won tentative approval from the FDA for a generic version of Claritin tablets, has signed a “semi-exclusive” development, license and supply agreement with Wyeth for this drug. Claritin is marketed by Schering-Plough Corp. for the relief of symptoms of seasonal allergic rhinitis, or hay fever.
Worldwide sales of the drug reached $3.2 billion in 2001.
Claritin is currently a prescription drug in the U.S., but Schering-Plough has filed an application to make it available over the counter.
Impax said the agreement with Wyeth relates to Impax’s generic version of Claritin-D 12-Hour and Claritin-D 24-Hour extended release tablets for the over-the-counter drug market.
Impax said that final approval from the FDA for its generic version of Claritin is subject to the resolution of a patent infringement lawsuit filed by Schering-Plough against Impax or the expiration of the 30-month stay process under the Hatch-Waxman Act amendments.