Lilly's end of the road on Evista looms with FDA nod for Teva generic

Courtesy of Eli Lilly

Eli Lilly ($LLY) is staring down the barrel of its Evista patent expiration. And Tuesday, Teva Pharmaceutical Industries ($TEVA) won FDA approval to load the bullet. The company's generic version of Lilly's breast cancer and osteoporosis drug got the green light, and Teva says it will hit the U.S. market within a month.

Evista brought in $772 million for Eli Lilly in the U.S. last year, about three-fourths of total Evista sales of $1.05 billion. It's far from Lilly's top seller; that would be Cymbalta, with $5 billion in 2013 sales. But with Cymbalta off patent in the U.S. as of December, Evista's numbers look a lot more important. And as far as patent expirations go, it's among the top 10 this year.

So, Evista is one reason why CFO Derica Rice called 2014 "the most financially challenging year" of Lilly's patent cliff. And now that Teva has FDA approval for its version, the Israeli drugmaker is revving up for a launch. Luckily for Lilly, Teva has 180-day exclusivity on the product, which means that severe price competition won't hit for 6 months after the drug makes its debut.

Lilly has been struggling to regain ground lost to Zyprexa's patent loss back in 2011, and to brace for the hit from Cymbalta and Evista generics. But a series of R&D setbacks left the company with few new products to fill the gap. Its Alimta cancer treatment is going strong at $2.7 billion, with 8% sales growth in the U.S. last year. And Cialis, the erectile dysfunction drug, brought in $2.15 billion, aided by significant direct-to-consumer ad spending--$88.9 million for the first half of 2013 alone.

Those drugs aren't enough, though, to keep Lilly's 2014 sales above $20 billion, CEO John Lechleiter's previously stated target. Early this year, the company said it wouldn't meet that goal, but stuck to its plans to deliver $3 billion in profits.

- see the release from Teva

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