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news.King Pharmaceuticals has said that Actavis, a manufacturer of generic pharmaceutical products headquartered in Iceland, has challenged a patent covering the company's chronic pain drug, Avinza.
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Bristol, Tennessee-based King Pharmaceuticals said that it “intends to vigorously enforce the patent.” The patent extends through November 25, 2017.
Under the federal Hatch-Waxman Act of 1984, any generic manufacturer may file an abbreviated new drug application challenging the validity or infringement of a patent listed in the FDA's approved drug products with therapeutic equivalence evaluations (the Orange Book) for a reference listed drug.