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US court delays Teva launch of generic Celebrex

Teva has lost its 180 days exclusivity for the generic version of Pfizer’s arthritis and chronic pain treatment.



The US Supreme Court of Appeal Court of Appeals has overturned the US Food and Drug Administration (FDA) decision allowing Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) to exclusively launch the first US Food and Drug Administration (FDA)-approved generic equivalent to Celebrex (Celecoxib) capsules in the US. Consequently, Teva will be compelled to wait until June 2015 before being allowed to launch the generic version of the arthritis, inflammation and chronic pain treatment, which earns Pfizer $3 billion annually.

Moreover, the court ruling will allow Teva’s rivals to launch generic versions of the treatment.

Last week Teva had announced that it would be immediately launching an exclusive version of generic Celebrex after becoming the first to receive FDA approval thus granting it 180 days generic exclusivity in the US.

Teva’s rivals Mylan, Watson and Lupin were eager to prevent the FDA from giving Teva 180 days exclusivity. The court ruled that the patent for Celebrex had expired and that Teva was not entitled to the exclusivity.


Published by Globes [online], Israel business news –

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