Even for a maker of generic drugs, getting two FDA drug approvals in as many business days is a feat not often seen. Teva Pharmaceuticals (Nasdaq: TEVA) managed to do it, though, bracketing the weekend with the good news.
On Friday, the company announced that it had received final FDA approval for its generic version of Novartis' (NYSE: NVS) Famvir tablets, which treat genital herpes. Teva was the first company to file an Abbreviated New Drug Application (ANDA), earning it a six-month exclusivity period before generic competitors such as Mylan Laboratories (NYSE: MYL) and Barr Pharmaceuticals (NYSE: BRL) can join it on the market.
Just when that exclusivity period will start will be determined by the courts. Teva and Novartis have been locked in a patent dispute over the drug since April 2005. Teva has a hearing next week to ask for a preliminary injunction, and both parties have agreed not to launch generic versions until after the court case.
Yesterday, Teva announced the second consecutive FDA approval, this time for a generic version of Pfizer's (NYSE: PFE) hypertension treatment Accupril. The company expects to be able to start shipping the drug shortly.
New drugs are the lifeblood of generic drug makers. While it's possible to grow revenues by taking market share from competitors, it's much easier for them to do it by increasing the number of products. If they can earn a few golden tickets -- those wonderful 180-day exclusivity periods -- along the way, then the bottom lines will grow even faster thanks to the higher margins during the exclusivity period.
Teva appears well on its way to growing both its top and bottom lines. As of the end of July, the company had 153 ANDA pending with the FDA, 40 of which were first-to-file applications. With that many drug applications pending, it's possible we might get to see another two-for in the not so distant future.
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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool's disclosure policy is far from generic.
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