- Teva and partner can't market Bendeka exclusively for 7 years
- Drugmaker planned to switch Treanda patients to Bendeka
U.S. regulators dealt a blow on Monday to Teva Pharmaceutical Industries Ltd.’s strategy to protect its No. 2 branded drug the same way the drugmaker shielded its top blockbuster from generic competition.
The Food and Drug Administration won’t let Teva and partner Eagle Pharmaceuticals Inc. market the cancer infusion Bendeka exclusively for seven years. Teva had planned to switch patients taking Treanda, an older drug with a longer infusion time that may face cheaper copycats this year, to Bendeka to protect its sales from erosion.
“Exclusivity would have removed threat of generic challenge well into the 2020’s,” Randall Stanicky, an analyst at RBC Capital Markets LLC in New York, wrote in a note to clients. “We are surprised by this decision.”
The strategy worked for Copaxone: sales of the drug are declining slowly because Teva converted 78 percent of U.S. patients to a 40-milligram version of the injection that has patent protection until 2030.
Treanda garnered $741 million in sales last year, making it Teva’s No. 2 branded medicine behind Copaxone. The drug’s sales declined 3 percent in 2015, but the drop may be closer to 20 percent this year, according to the average of 12 estimates compiled by Bloomberg.
Eagle said it is evaluating all options to challenge the FDA’s “incorrect” decision. Teva “cannot confirm any future related actions,” the company said in response to e-mailed questions.