It's not a megabrand like Lipitor or Plavix, but the diabetes drug Actos has brought in more than $3 billion in U.S. sales at its peak, and more than $16 billion total since its release in 1999. And now, it has generic competition. Takeda Pharmaceuticals, watch your back.
Ranbaxy Laboratories rolled out its version of Actos today, beginning its 180 days of exclusivity on the market. It's not completely exclusive; Mylan ($MYL) shares those rights. Their dual entree may spell a bigger discount against the branded price--and therefore, a bigger threat to Takeda's Actos revenue.
The diabetes drug has already been flagging. Safety questions have dogged Actos, including a potential increase in the risk of bladder cancer. It has a "black box" warning for congestive heart failure risks. The company faces a rash of patient lawsuits.
Still, Actos accounted for about 18% of Takeda's 2011 revenue--and a whopping 51.8% of U.S. revenue. The Japanese drugmaker now expects profit to drop 40% over the next few years. It's laying off 2,800 people in the U.S. and Europe to preserve margins as much as it can.
Ranbaxy's launch dispels speculation that it might have to relinquish its Actos exclusivity as part of its consent decree with the FDA. In settling longstanding manufacturing probes with the U.S. government, Ranbaxy agreed to give up 180-day exclusivity on three unidentified products. Obviously, Actos wasn't one of them.
- see the Reuters story
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