On Thursday, the United States District Court for the District of New Jersey approved the compromise agreement between Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA ; TASE: TEVA) and Wyeth (NYSE: WYE) over Teva's application to market a generic version of Wyeth's anti-depressant Effexor. The agreement was signed in October. At the beginning of December, it was reported that the US Federal Trade Commission would not oppose the settlement.
Under the compromise agreement, Teva will be able to market generic Effexor. The brand drug has annual sales of $2.5 billion. Teva and Wyeth have not disclosed details of the agreement between them, but it appears that Teva will be able to enter the market with its generic version close to the date on which the main patent on the drug expires, in June 2008, and will not have to wait unil 2017, when the remaining patents will expire.
Merrill Lynch estimates that, as a result of the settlement, Teva will generate sales of $212 million, which will add $0.10 to its quarterly earnings per share. This estimate is based on sales of $2.4 billion for Effexor in 2007.
Teva has also announced tentative FDA approval for its Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 250 mg and 500 mg. The company said final approval of this product is anticipated upon expiration of patent protection for the brand product in January 2008.
Upon final approval, Teva's Divalproex Sodium Delayed-Release Tablets will be the AB-rated generic equivalent of Abbott's Depakote Tablets. This product is indicated for treatment of manic episodes associated with bipolar disorder, prophylaxis of migraine headaches, and as therapy in several types of epileptic disorders.
According to Teva, the brand product has annual sales of approximately $813 million.
Teva began 2006 with tenetative FDA approval for its ANDA (abbreviated new drug application) for Simvastatin Tablets, the generic equivalent of Merck's Zocor Tablets, a product indicated for the treatment of high cholesterol.
The brand product has annual sales of approximately $4.4 billion.
Teva shares closed at $43.40 on Friday, giving the company a market cap of $26.76 billion.
Published by Globes [online], Israel business news - www.globes.co.il - on January 15, 2006