Teva Gets FDA Nod For Generic Acid Reflux Drug, Prevacid - Update

Tuesday, generic-drug maker Teva Pharmaceutical Industries Ltd. (TEVA) said the U.S. Food and Drug Administration granted it final approval to market the generic version of Tap Pharmaceutical's proton pump inhibitor Prevacid.

The Israel-based company's Abbreviated New Drug Application for Prevacid, generically known as lansoprazole, was approved by the FDA for delayed-release capsules of 15 mg and 30 mg. Teva plans to launch the product on Wednesday.

Lansoprazole is intended for treatment of acid reflux, heartburn, and stomach ulcers. Annual sales of the brand product were $2.97 billion in the U.S. for the twelve months ended June 30, 2009.

Earlier today, Teva announced that the U.S. District Court for the District of Delaware dismissed patent infringement allegations over its Abbreviated New Drug Application for marketing the generic version of Prevacid SoluTab, manufactured by Japan's largest pharmaceutical company Takeda Pharmaceuticals. The court found Teva's generic lansoprazole orally-disintegrating tablets do not infringe U.S. Patent No. 5,464,632 held by Takeda.

In an earlier judgment in March, U.S. District Judge Sue Robinson had ruled that Teva's generic drug infringes one of the two patents held by Takeda. The court ruled that Teva infringed patent covering the lansoprazole compound while it dismissed allegations of infringement over patent covering a composition of lansoprazole. The court had ruled that the lansoprazole and magnesium carbonate in Teva's product are not "in contact ... evenly" as required by the claims and therefore is not an infringement of the '321 patent.

While Teva had conceded during trial that its generic drug infringes the '098 patent, it argued that the patent, along with '321 patent, were invalid for obviousness and unenforceable due to inequitable conduct. The court had rejected Teva's argument that the patents were obvious.

Tap Pharmaceuticals was formed as a joint venture between Abbott Laboratories (ABT) and Takeda in 1977. The joint venture was dissolved in 2008 and most of the company merged with Takeda in 2008.

TEVA closed Tuesday's regular trading at $52.77, down $0.43 or 0.81%, on a volume of 1.58 million shares on the Nasdaq.

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