Actavis challenges King's Avinza patent with ANDA filing

23 September 2007

Iceland-based generic drugmaker Actavis has initiated a challenge of the patent listed in connection with USA-based King Pharmaceuticals' painkiller Avinza (morphine sulfate extended-release capsules). Actavis believes that it is the first company to file an Abbreviated New Drug Application containing a Paragraph IV certification for the agent. The firm says it filed its ANDA with the US Food and Drug Administration in June 2007. King intends to enforce its patent. Avinza capsules are a modified-release formulation of morphine sulfate intended for once-daily administration and indicated for the relief of moderate-to-severe pain needing constant, around-the-clock therapy for an extended period of time. The product had annual sales of approximately $169.0 million for the 12-month period ending June 2007, according to IMS Health data.

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