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    INDIANAPOLIS — The maker of erectile dysfunction drug Cialis wants its pill sold to men without a prescription. (LLY) and French drugmaker Sanofi (SAN), Cialis could become the first prescription drug for male impotence to be sold over the counter. The plan still needs approval from regulators, who would weigh the risks of allowing the drug to be sold without a doctor's visit. The two companies hope for a 2018 launch of what they're calling Cialis OTC. That's the same year patents for Cialis are expected to expire in the United States and Europe, allowing cheaper generics to take over and effectively dry up Lilly's considerable profits from the drug. Cialis generated $2.16 billion in sales last year and was Lilly's fourth best-selling drug. A plan to sell Cialis over the counter would allow the Indianapolis drugmaker to continue to profit from the drug as an impotence treatment. Lilly didn't reveal financial details of the deal with Sanofi. With the agreement, Lilly extends the runway for Cialis, staving off a more immediate blow to revenues. That generic threat still looms in the near-future, however, and will post a challenge to Lilly's financial growth. The Indianapolis drugmaker has committed to hitting 5% annual revenue growth through 2020, betting a wave of new drugs will help see it through another rough patch of patent expiries. Copycat versions of Eli Lilly's ADHD drug Strattera (atomoxetine) launched earlier this year, and the company anticipates losing exclusivity for its blood-thinner Effient (prasugrel) in October. K.'s top court, however, should help Lilly defend its cancer drug Alimta (pemetrexed), which also faces inbound rivals. Cialis is Lilly's second best-selling product and accounted for nearly 12% of total revenues last year with $2.47 billion in sales. S., recent growth has come from higher realized prices as the pharma anticipates the looming patent cliff. "We expect that the entry of generic competition following the loss of exclusivity will cause a rapid and severe decline in revenue," the company stated in its year-end filing with the Securities and Exchange Commission. Such a steep decline will be a heavy blow for Lilly's bottom line, even if it comes a year later than previously expected. In 2013, sales of its antidepressent and pain drug Cymbalta (duloxetine) topped $5 billion — only to collapse down to $1.6 billion the next year after its patent protection expired.

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  4. Cialis' patent is set to expire next year, making it the latest in a string of Eli Lilly and Co. blockbusters that will face low-priced generic.

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