Once-a-day version of Lilly’s Cialis gets OK from FDA
In a move that could help give Indianapolis drugmaker Eli Lilly and Co. an edge over its rivals in the growing market for erectile dysfunction, the U.S. Food and Drug Administration has approved Cialis for daily use.
The once-a-day version will be marketed for men who anticipate having sex two or more times a week, without confining it to a limited time frame. The current dosage of Cialis works for about 36 hours. Viagra and the other major erectile-dysfunction drug, Levitra, work for about four hours.
When Cialis is taken daily, men can attempt sexual activity at any time between doses. The low-dose daily version of the drug is already available in parts of Europe, Lilly said. Neither Viagra nor Levitra, a pair of competitors, is sold in once-daily doses.
Cialis has continued to gain market share since it was launched in 2003, Lilly said. And any continued improvement in Cialis results likely will help the bottom line at Lilly, which last year bought full control of the drug from partner Icos Corp. for $2.3 billion.
Sales of Cialis were $798 million for the first nine months of 2007, up about 30 percent over the same period a year earlier. Lilly says the drug is expected to top $1 billion in sales for the full year. The company will report year-end earnings on Jan. 29.
Cialis trails rival Viagra in the U.S., but it’s the leader in 22 nations, from France to Mexico, in the $3 billion worldwide market for erectile dysfunction.
Lilly launched Cialis in 2003 — five years after competitor Pfizer launched Viagra, a brand that has become a household name.
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