Teva may lose patent case on Famvir (famciclovir) herpes drug generic to Novartis: Report

World’s top generic maker is likely to lose its first patent challenge over genital herpes drug Famvir  (famciclovir) to Novartis, reports said.

Teva’s motion to dismiss two suits alleging patent violations over the anti-viral Famvir (famciclovir), were rejected by the U.S. District Court of New Jersey.

Teva sought permission from US FDA to market its generic version of Novartis Famvir (famciclovir) a under Paragraph 4 of the Hatch-Waxman Act.

The Para IV filing entitles to have six months of exclusivity to the first company that produces a generic version and successfully challenges the validity of a patent protecting a drug.

Teva launched its generic version of Famvir (famciclovir) in September 2007. So Teva took the risk of losing the patent as part of its strategy of launching generic versions of drugs before it wins patent challenges.

In fact, Teva’s strategy has helped it to net profit from its generic version of Famvir (famciclovir), which cloaked a total sale of $190 million in the 12 months before Teva launched the generic drug.

However, now Teva risk losing the patent making it vulnerable to pay damages to Novartis that developed the original Famvir (famciclovir).

Investments firm predicts Teva will lose the patent challenge on Famvir (famciclovir).

In that case, damages can be as much as three times the profits lost by the original company, if it can prove a deliberate violation of a valid patent, reports said.

In December 2007, Teva launched a generic version of $2.5 billion Protonix, a drug developed by Wyeth for treating acidity.

Similarly, Teva launched Lotrel, a high blood-pressure drug in May 2007.

Recently, Teva Pharmaceutical Industries Ltd won U.S. Food and Drug Administration’s final approval for its Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical’s proton pump inhibitor Prevacid (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg. Customers will begin receiving product on November 11, 2009.

Annual sales of Prevacid Delayed-Release Capsules were approximately $2.97 billion in the United States for the twelve months that ended June 30, 2009 based on IMS sales data.

Headquartered in Israel, Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company specializing in the development, production and marketing of generic and proprietary branded pharmaceuticals and active pharmaceutical ingredients. Teva is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world.

Teva operates through a network of worldwide subsidiaries. More than 80% of Teva’s sales, which totaled US$11.1 billion in 2008, are in North America and Europe. Teva has over 38,000 employees worldwide and production facilities in Israel, North America, Europe and Latin America.