U.S. Clears Mylan's Generic Rival to J&J Pain Patch
Fri Jan 28, 2005 05:51 PM ET
LOS ANGELES (Reuters) - U.S. regulators approved the first generic rival to Johnson & Johnson's
Duragesic pain relief skin patch, the U.S. Food and Drug Administration said on Friday.
Mylan Laboratories Inc. said it will produce several different strengths of the patch, known generically as the
fentanyl transdermal system, and launch the product immediately.
Johnson & Johnson's annual sales of the patch total about $1.63 billion.
Mylan, the biggest U.S. maker of generic drugs, had hoped to launch its copycat version last year, but the FDA granted J&J an additional six months of market exclusivity in return for testing the drug's safety and effectiveness in children.
Shares of Mylan, which fell 4 cents to close at $16.60 on the New York Stock Exchange, were higher at $17 after hours. Shares of J&J, which rose 40 cents to close at $64.62, were little changed after hours. (Additional reporting by Deena Beasley in Los Angeles)