PHARMACY

Teva, subsidiaries accused of patent infringement, false advertising

BY Alaric DeArment

WAYNE, N.J. Two divisions of Bayer have filed a lawsuit against Teva Pharmaceutical Industries and two of its subsidiaries concerning a recently launched generic version of a popular Bayer contraceptive drug.

Bayer HealthCare Pharmaceuticals and Bayer Schering Pharma announced Tuesday that they had sued Teva, Barr Pharmaceuticals and Barr Labs in the U.S. District Court for the Northern District of Illinois, alleging patent infringement and false advertising in Teva’s marketing of Gianvi (drospirenone and ethinyl estradiol) tablets. Teva launched Gianvi on June 1, marketing it as a generic version of Bayer’s Yaz.

Specifically, according to the suit, the prescribing information for Gianvi reads that the drug uses the chemical beta-cyclodextrin as a “clathrate” to stabilize and prolong the shelf life of the active ingredient. But Bayer said it tested Gianvi tablets and was of the opinion that they did not use beta-cyclodextrin as a clathrate.

Bayer said it was seeking a temporary restraining order and preliminary injunction to stop Teva from making what it called false claims about Gianvi and, in its view, infringing the patent that covers Yaz. Bayer is also asking Teva to “correct any erroneous impression persons may have derived” concerning Gianvi. Yaz had $782 million in sales in 2009, according to IMS Health.

Teva could not be reached for comment.

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Gilead patent for Ranexa challenged by Lupin

BY Alaric DeArment

FOSTER CITY, Calif. Indian generic drug maker Lupin is challenging a Gilead Sciences patent for a drug that treats chronic angina, Gilead said.

Gilead said it received a notice that Lupin had filed an approval application with the Food and Drug Administration for a generic version of Ranexa (ranolazine) extended-release tablets. Lupin’s application contained a Paragraph IV certification, a legal assertion under the Hatch-Waxman Act of 1984 that Gilead’s patents covering Ranexa are invalid, unenforceable or won’t be infringed by Lupin’s version.

Under the Hatch-Waxman Act, Gilead has 45 days from the receipt of the letter to file a patent infringement lawsuit against Lupin. Such a suit would prohibit the FDA from approving Lupin’s version of the drug for two and a half years or until the court rules against Gilead. The patents covering Ranexa are set to expire in 2019, according to FDA records.

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Taro sales rise in Q1

BY Alaric DeArment

HAWTHORNE, N.Y. First-quarter sales for Taro Pharmaceutical Industries increased by 5.2% to $89.3 million from $84.9 million in first quarter 2009, the Israeli generic drug maker said Monday.

Profit for the quarter was $10.2 million, compared with $11.1 million in first quarter 2009, including a $3.8 million decrease resulting from foreign exchange expenses related to changes in rates between the U.S. and Canadian dollars.

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