Actavis files ANDA at FDA for generic Abraxane (paclitaxel protein-bound particles for injectable suspension)- Celgene
Celgene Corporation has announced it has received a Paragraph IV Notice Letter advising that Actavis LLC submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking authorization from the FDA to manufacture and market a generic version of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) 100 mg/vial in the United States. The Notice Letter contains Paragraph IV certifications against certain patents relating to Abraxane. Celgene is assessing the notice. Celgene intends to vigorously defend its extensive intellectual property rights relating to Abraxane.
Comment: Celgene claims patent protection for Abraxane to 2026 in the US and to 2022 in the EU.
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