For those concerned with the potential damage caused by the proliferation of generic versions of dangerous medicines like Levaquin, there is some good news.
A U.S. Federal Court has ruled that India’s fifth-largest pharma giant, Lupin, cannot market a generic formulation of Levaquin in the United States — at least not yet. The court upheld a ruling granting Ortho-McNeil’s request to extend its patent protection on the medicine. This is, of course, not a final answer, as all protections do expire eventually, but it does mean that for a little longer at least there is a stop on the production of a generic version until December 2010.
Levaquin is an antibiotic used to treat infections that primarily of the prostate and for infections that don’t respond well to other medications. However, it also has been linked to tendon deterioration that ultimately results in a tendon rupture, particularly in the Achilles tendons of the ankles. These conditions are often very painful, and can severely inhibit mobility. Some tendon ruptures take up to 12 months to heal when immobilized in a plaster cast.
At most, however, this is a temporary reprieve. Lupin is considered highly likely to file an appeal to a higher U.S. court. There is just too much money involved in Levaquin sales for any other decision; the drug has done $1.4 billion in sales in recent years. Even if the decision is upheld, though, the extension is only until the end of this year. At that point, it is unlikely that any further protections on the patent will be allowed, and companies such as Lupin will be permitted to make their generic offerings.
There are also other companies, such as generic manufacturer Mylan, that are eager to get in on the business. Their appeals have been denied as well, but it is unfortunately only a matter of time.