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news.The Perrigo Company, a manufacturer of over-the-counter pharmaceutical products, has settled all Hatch-Waxman litigation relating to desloratadine tablets, with the company taking a license under all relevant patents.
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Previously, Perrigo was sued for patent infringement of US patents based upon its filing of an abbreviated new drug application containing a Paragraph IV certification. Under the terms of the settlement, Perrigo can commercially launch its generic desloratadine product on July 1, 2012, or earlier in certain circumstances.
The new product launch may be a prescription or over-the-counter (OTC) product depending on its status at the time of launch. The Perrigo product is awaiting the FDA’s approval.
This product seeks an AB-rating as equivalent to Schering-Plough’s Clarinex tablets (5mg) indicated for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria.
Joseph Papa, Perrigo’s chairman and CEO, said: “This is another example of Perrigo’s continued commitment to bring new products to the market. Perrigo continues to be focused on our mission of making quality healthcare more affordable for consumers.”