ALLEGAN, Mich., Sept. 27 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) announced today that it had filed an Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg, a generic version of Mucinex(R).
Mucinex (guaifenesin extended-release tablets, 600 mg), an expectorant indicated to relieve chest congestion and make coughs more productive, had sales of approximately $120 million through food, drug and mass merchandisers for the 12 months ended August 2007, as measured by Information Resources, Inc. and ACNielsen.
Perrigo filed its ANDA for Guaifenesin Extended-Release Tablets, 600 mg containing a Paragraph IV Certification with the U.S. Food & Drug Administration. Subsequently, Perrigo notified Adams Respiratory Therapeutics, Inc., the New Drug Application holder and patent owner for Mucinex of its filing. Today, Adams announced it filed suit alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the patent process under the Hatch-Waxman Act.
Perrigo's President and CEO Joseph C. Papa concluded, "This filing reflects our continuing investment in new products. As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders."
Perrigo Company is a leading global healthcare supplier and the world's
largest manufacturer of over-the-counter (OTC) pharmaceutical and
nutritional products for the store brand market. Store brand products are
sold by food, drug, mass merchandise, dollar store and club store retailers
under their own labels. The
|SOURCE Perrigo Company|
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