A US federal appeals court upheld a lower court ruling rejecting an appeal by rival generic drugmaker Apotex.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) now appears to have finally won its battle to keep exclusivity over Pravachol. In a ruling yesterday, the US Court of Appeals for the District of Columbia Circuit agreed with a lower court judge who refused to grant Canadian generic drugmaker Apotex Inc. an injunction barring the US Food and Drug Administration (FDA) from allowing Teva to begin exclusive marketing of generic Pravachol. The exclusivity period will enable Teva to make huge profits once the drug is launched on the market. Teva began marketing Pravachol as soon as it was granted exclusivity at the end of April.
Pravachol, which is approved to treat patients with high cholesterol who are at risk for heart attack, stroke or other cardiovascular complications, will have annual sales of $1.5 billion. The generic version of the drug is pravastine sodium, and the ethical version was developed by Bristol Myers Squibb (NYSE: BMY).
The patent on the drug expired in April 2006, following which Teva was supposed to launch its generic version and receive six months exclusivity. Apotex claimed that it already had exclusivity on the drug from 2004, when it reached an agreement with Bristol Myers who undertook not to sue it if it launched its own generic version. The FDA accepted Apotex’s claim but Teva then appealed to the US courts, which restored Teva’s exclusivity and overturned the FDA ruling. This decision was upheld yesterday by the appeals court, which sent the case back to the lower court for further proceedings, but said Apotex had "little likelihood of succeeding" in the dispute.
Published by Globes [online], Israel business news - www.globes.co.il - on June 7, 2006
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