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Generic Competition Set to Dig Into J&J Sales as FDA Approves 12 Levaquin Clones

By June 24, 2011July 10th, 2019Uncategorized

There is sad news for Johnson & Johnson, as the U.S. Food and Drug Administration has approved the first generic versions of the drug giant’s popular, but controversial, antibiotic Levaquin (levofloxacin). The applications to manufacture generic versions of the drug were filed by 12 different companies. Some of those companies include:

  • Akorn
  • Dr. Reddys Laboratories
  • Mylan Pharmaceuticals
  • Teva
  • Aurobindo Pharma
  • Glenmark Generics
  • Lupin
  • Wockhardt

These companies and others are now allowed to sell their versions of Levaquin in the United States, which so far has earned $ 1.45 billion for a period of 12 months ending in September, 2010. The FDA approved the drug to be sold in tablet form, as an oral solution and as an injectable solution.

“Generic drugs are important options that allow greater access to health care for Americans,” said Keith Webber, Office of Pharmaceutical Science Deputy Director, FDA. “FDA-approved generic drugs must meet rigorous standards and are required to be of high quality so that people can be assured that their medications will act the same in the body as the brand-name product.”

The fact that Levaquin is still so widely used after countless information has been released about the risks of tendon ruptures and injuries may be surprising enough, but even the numerous lawsuits filed against the makers of the drug will not put a dent in the billion-dollar sales. Johnson & Johnson’s Levaquin is only one of many drugs whose patent expiry sets them up for generic competition; however, the competition has yet to put a drug company out of business.

Levofloxacin is currently being used to treat bacterial infections in the skin, sinus infections, as well as infections of the kidneys, bladder and prostate. The drug has also been used as a treatment for certain bacterial infections that cause bronchitis and pneumonia — it even helps treat those people who have been exposed to inhalational anthrax, says the FDA.