PHILADELPHIA, Aug. 23 /PRNewswire/ -- United Research Laboratories, Inc. and Mutual Pharmaceutical Company, Inc. (“Mutual”) today announce that Mutual has notified Adams Respiratory Therapeutics that Mutual has filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) for Mutual’s guaifenesin extended-release tablets, 600 mg and 1200 mg, which are the generic equivalent to Adams’ Mucinex® brand. Mutual has filed a Paragraph IV Certification, asserting that the Adams patents listed in the Orange Book are invalid, unenforceable, and will not be infringed upon by Mutual’s guaifenesin formulation (i.e., that these patents do not and cannot block Mutual’s entry on this product). Mutual intends to market its product immediately upon receiving FDA approval.
“We are looking forward to bringing competition to the marketplace as was intended under the Waxman-Hatch Act. This Paragraph IV ANDA filing is unique in the pharmaceutical industry. Our matrix product with no layers was on sale for years before Adams filed for its patents. In fact, our product was available up until the time that Adams received FDA approval and FDA required all other extended-release guaifenesin products to come off the market. We believe a law-abiding company must take this unique circumstance into consideration and conclude that there is no basis for a patent lawsuit. Of course, if Adams does bring a patent lawsuit, we are confident it will be dismissed promptly and expose Adams to tremendous risk of antitrust damages as the patents are clearly not applicable to us,” says Richard H. Roberts, M.D., Ph.D., President and Chief Executive Officer of United Research Laboratories/Mutual Pharmaceutical Company.
A copy of Mutual’s communication with Adams regarding this matter is available at http://www.urlmutual.com/guaifenesin2.pdf.
About United Research Laboratories/Mutual Pharmaceutical Company
United Research Laboratories/Mutual Pharmaceutical Company is a leading national supplier of prescription pharmaceutical products. It manufactures and distributes one of the most extensive product lines in the generic industry and has a rapidly growing pipeline of generic and branded products. Since the company’s inception in 1946, it has accumulated 250 abbreviated new drug application (ANDA) approvals and four new drug application (NDA) approvals from the U.S. Food & Drug Administration. The company’s branded affiliate, AR Scientific, distributes the antibiotics Bactrim and Bactrim DS and the only FDA approved Quinine Sulfate product, Qualaquin(TM). URL/Mutual currently manufactures 2.4 billion tablets and capsules per year and has the capacity to manufacture 4.5 billion. URL/Mutual is a privately held, Philadelphia-based company that has had 6 years of growth in Revenue and EBITDA. 2005 Net Revenue was over $306 million and EBITDA over $100 million.
To learn more about URL/Mutual, they will be presenting at the 2006 UBS Global Lifesciences Conference in NYC on Sept. 25th to 28th.
For further information, please call 215-697-1900 for Richard P. Foster, Vice President, Marketing and Strategic Analysis, or visit www.urlmutual.com.
Source: United Research Laboratories/Mutual Pharmaceutical Company
