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New Exclusivity For Fixed-Dose Drugs Will Help Small Cos.

Law360, New York (April 28, 2014, 3:36 PM EDT) -- Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with chronic conditions, such as diabetes,[1] cardiovascular disease[2] and infectious disease.[3] In fact, within the last two decades, the U.S. Food and Drug Administration approved 19 new drug applications for fixed-dose combination drugs containing at least one new drug substance.[4] More than half of these NDAs were approved in the last seven years.[5]

As with the development of any pharmaceutical product, developers of fixed-dose combination drugs seek to maximize the patent protection and market exclusivities provided by the U.S. Patent and Trademark Office and FDA respectively. Thus, it...

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