Generic Levaquin Is in the Pipeline

Washington, DCThe potential for adverse responses to Levaquin increases with the expiry of Johnson & Johnson's (J&J) patent for levofloxacin, as it paves the way for generic manufacturers to introduce new sources of Levaquin into the drug market.

It was announced on December 4 that Mylan Pharmaceuticals has been granted tentative approval by the US Food and Drug Administration (FDA) to market a generic form of the fluoroquinolone antibiotic in 250, 500 and 750 mg tablets. It is not known when Mylan will bring its generic form of Levaquin to market.

Levofloxacin, a fluoroquinolone antibiotic, is a powerful drug used to treat a range of bacterial sinus and bronchial infections as well as certain genitourinary infections and bacterial skin infections. Critics have long derided the drug for its plethora of side effects ranging from tendon rupture to neurological disorders.

Will there be more Levaquin lawsuits?

With the inclusion of Levaquin in the ranks of the generics, it appears that things may get worse before they get better. Currently, Levaquin is out of reach to patients who cannot afford the expensive brand-name drug or whose health plan does not shoulder the cost. Generics, on the other hand, are usually less expensive. The generic version of Levaquin will undoubtedly introduce the antibiotic to a new sector of the population and a new generation of users.

There are other generic manufactures besides Mylan that have lined up for approval to manufacture and market fluoroquinolones. Ivax, Actavis and Lupin Pharmaceuticals have also gained tentative FDA approval to market generic versions of Levaquin.

The introduction of generics is expected to take a bite out of Johnson & Johnson's market share for Levaquin. According to the December 9 issue of Generic Line, the company reported $15.9 million in sales of Levaquin in 2008.

To that end, Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the patent expiries of three blockbuster antibiotics—levofloxacin, moxifloxacin and piperacillin/tazobactam—will be the primary factors contributing to a decline of more than 15 percent in the community-acquired pneumonia drug market though 2018.

Recent court decisions have exonerated manufacturers of brand drugs from liability over the failings of their generic counterparts, even though generic manufacturers make generic drugs and their labeling inherently similar to the brand versions.