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Sanofi-Aventis Acts to Stop Planned Generic of Allegra

Posted on: Wednesday, 21 September 2005, 21:00 CDT

Sep. 22--Sanofi-Aventis on Wednesday took legal action to protect its Allegra allergy pill.

The company is seeking an injunction to either stop Barr Pharmaceutical and Teva Pharmaceutical Industries Ltd. from marketing a generic version of Allegra, or expedite a legal battle over the drug's patents, a Barr statement said.

Sanofi-Aventis, with U.S. headquarters in Bridgewater, also asked the court to stop Ranbaxy Laboratories Ltd. and Amino Chemicals Ltd. from producing raw materials for the generic, the statement said.

Sanofi-Aventis filed the injunction in U.S. District Court with Amino Chemicals Ltd., which helped develop Allegra.

The legal maneuver comes two weeks after Barr and Teva announced an agreement to make generic tablets of Allegra, which had $1.4 billion in sales in the 12 months ending in June.

Under the agreement, Barr sought approval from the U.S. Food and Drug Administration for the generic, which is called fexofenadine hydrochloride, the Barr statement said. "Teva launched the drug and has been shipping product to customers since that time," it said.

Barr CEO Bruce L. Downey said, "We intend to vigorously oppose this effort to prevent the marketing of a more affordable generic fexofenadine."

"We hold multiple patents relating to Allegra," said Sanofi-Aventis spokeswoman Melissa Feltmann.

She said the company believes that the Barr-Teva generic violates those patents, adding that "we will continue to vigorously defend our rights."

Four days after Barr and Teva announced their generic Allegra, Sanofi-Aventis said it had signed an agreement to launch its own generic of the drug.

Barr and Sanofi-Aventis have been sparring in court over Allegra since 2001 when Barr, of Woodcliff Lake, sought approval from the FDA for a generic version of the drug. Shortly afterward, Sanofi-Aventis filed suit to stop the sale of the generic until 2018, when several Allegra patents expire.

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Copyright (c) 2005, The Record, Hackensack, N.J.

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SNY, SAN, BRL, TEVA, RBXZF, RANB,

Source: The Record - Hackensack, New Jersey

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