The lawsuit is the result of an Abbreviated New Drug Application (ANDA) filed by Mutual with the U.S. Food and Drug Administration (FDA) concerning Mutual's intent to market a generic version of felodipine in the US. Felodipine is marketed in the US and internationally by AstraZeneca under the brand name Plendil®. Plendil is a long-acting calcium channel blocker.
The basis for AstraZeneca's complaint is that the action by Mutual infringes upon a formulation patent for Plendil, which provides protection to the year 2007. The substance patent for felodipine, which expires in 2001, has not been challenged by Mutual. AstraZeneca intends to fully enforce all of its patents.
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Steve Brown
+44 (0)20 7304 5033
Lucy Williams
+44 (0)20 7304 5034
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- AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products.
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