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ALLEGAN, Mich. — Perrigo Co. has gained final approval from the Food and Drug Administration for desloratadine tablets (5 mg), an allergy medication.
Perrigo said Tuesday that it had been sued for patent infringement based upon its filing of an abbreviated new drug application (ANDA) containing a Paragraph IV certification and settled the case in 2008.
Under the settlement, Perrigo can commercially launch its generic desloratadine product on July 1, 2012, or earlier in certain circumstances, according to the company, which added that the new product launch may be a prescription or over-the-counter product depending on its status at the time of launch.
This product is an AB-rating as equivalent to Schering-Plough’s Clarinex tablets (5 mg), indicated for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis, Perrigo said. Sales for the brand were approximately $185 million, based on Wolters Kluwer data.
