Merck Sharp & Dohme Pharmaceuticals (MSD) has filed a patent infringement complaint in the US District Court for the District of New Jersey against Teva Pharmaceutical Industries alleging infringement of the US 5,565,473 (the ‘473 patent) protecting Montelukast sodium, the active ingredient of MSD’s SINGULAIR. The complaint is to prevent the US FDA from approving Teva’s abbreviated new drug application (ANDA) No. 78-605 for generic montelukast sodium tablets before expiry of the ‘473 patent. In its complaint, MSD argued that Teva has no adequate good faith basis for filing its ANDA containing certification of the invalidity, unenforceability, and/or non-infringement of the claims of the ‘473 patent.
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