Pfizer settles US patent litigation with Actavis over generic Celebrex

Pfizer settled patent litigation allowing Actavis to launch a generic version of Celebrex (celecoxib) in the US beginning in December 2014, or earlier under certain circumstances, Actavis reported Thursday. The company suggested that it may be the first to file an application for a generic version of the drug with the FDA and thus may be entitled to 180 days of market exclusivity or shared exclusivity. Actavis previously said that it expected to launch its generic version of the therapy in May.

Last month, a US district court invalidated a patent that would have protected Celebrex from generic competition until December 2, 2015, with Pfizer pledging to continue its defence of the patent. The drugmaker indicated that the licensing agreement with Actavis will be royalty-bearing throughout the remainder of the term of the patent, adding that the remaining terms of the deal are confidential.

Pfizer reached a similar agreement with Teva earlier this month, with the latter suggesting that it may hold first-to-file rights on at least three dosages of the generic. Meanwhile, Mylan, which has received tentative FDA approval of its generic version of Celebrex, said that it plans to launch its formulation next month.

Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, and for the management of acute pain in adults, generated US sales of around $2.2 billion last year.

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