Levofloxacin - History

History

Levofloxacin is a fluoroquinolone antibiotic, marketed by Sanofi-Aventis under the tradename "Tavanic". Levaquin is also marketed worldwide for oral and IV use, as well as used in ophthalmic solutions. Daiichi Sankyo had granted an exclusive license to Sanofi-Aventis to make, use and sell pharmaceutical preparations containing levofloxacin in the UK and Mexico. Other manufacturers include Novell Pharmaceutical Laboratories (Levores).

Levaquin has proven to be a blockbuster drug for Johnson and Johnson / Ortho McNeil, generating billions of dollars in additional revenue. In 2007 alone, Levaquin accounted for 6.5% of Johnson and Johnson's total revenue, generating $1.6 billion, an 8% increase over the previous year. Ranking 37th within the top 200 prescribed drugs in the United States for 2007, and ranked 19th in world sales in 2007, total sales for Levaquin were in excess of 1.6 billion dollars. Levaquin was the most prescribed fluoroquinolone drug in the world for 2007.

Levofloxacin was first patented in 1987 (Levofloxacin European patent – Daiichi Pharmaceutical Co., Ltd.) and was approved by the United States Food and Drug Administration on 20 December 1996 for use in the United States to treat bacterial sinusitus, bacterial exacerbations of bronchitis, community-acquired pneumonia, uncomplicated skin infections, complicated urinary tract infections, and acute pyelonephritis. Levofloxacin is described in some publications as a second generation fluoroquinolone. Other publications describe it as a third-generation fluoroquinolone.

Levofloxacin is considered to be same as Ofloxacin by the U.S. Food and Drug Administration (FDA), with the exception of the potency shown in vitro against mycobacteria. In vitro, it is, in general, twice as potent as ofloxacin, whereas d-ofloxacin is less active against mycobacteria.

The current United States patent is held by Ortho-McNeil-Janssen. Ranked 19th in world sales in 2007, sales for Levaquin exceeded $1.4 billion. Levaquin was the most prescribed fluoroquinolone drug in the world for 2007.

Levaquin sample boxes showed a macron over the letter "e," indicating pronunciation with a long-"e" sound, although Merriam-Webster indicates a short-"e" pronunciation. Levofloxacin would typically be pronounced with the long-e from the Latin prefix "levo-" (meaning left).

Levofloxacin is marketed worldwide under many brand names, making post-marketing surveillance difficult.

In addition, generic versions of levofloxacin had been available since 2004 and marketed as a generic drug under a variety of different brand names. However, Daiichi Sankyo-Johnson and Johnson-Ortho McNeil filed numerous patent lawsuits to prevent such generic equivalents from being marketed, claiming that their patent did not expire until 23 June 2009. see Generic equivalents