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news.GeoPharma has reached an agreement with Schering, Sepracor and the University of Massachusetts settling all Hatch-Waxman litigation relating to desloratadine tablets 5mg, with the company receiving a license under all relevant patents.
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The agreement provides for potential modification of select terms based on certain events and developments. The specific financial terms and conditions of the agreement have not been disclosed. The agreement is subject to review by the US Federal Trade Commission and Department of Justice.
Under the terms of the settlement, GeoPharma can commercially launch its generic desloratadine product, with six months marketing co-exclusivity, on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or over-the-counter product depending on its status at the time of launch.
The GeoPharma product is pending FDA approval and seeks an AB-rating as equivalent to Schering’s Clarinex tablets indicated for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis.
Mihir Taneja, GeoPharma’s CEO, said: We are very pleased with the settlement. This major milestone for the company validates our strategic generic drug manufacturing plans and we, along with our exclusive supplier of the desloratadine active pharmaceutical ingredient, Morepen Laboratories, will be well prepared to take advantage of the opportunity upon the commercial launch date.