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Teva launches first U.S. generic Cialis as Eli Lilly braces for loss of its ED blockbuster 2018-09-29
By Arlene Weintraub

It’s time to say goodbye to the bathtub couples who've been a staple of direct-to-consumer drug advertising since 2003—and who helped turn Eli Lilly’s erectile dysfunction drug Cialis into a billion-dollar-plus blockbuster.

Teva Pharmaceutical said Thursday it is launching its generic version of Cialis in the U.S. The company has “first-to-file” status on the product, which means that for 180 days it will have the market all to itself before the FDA starts greenlighting other generics.

This is not the first blow to Cialis—the product’s sales started eroding when generic versions of Pfizer’s rival ED drug, Viagra, hit the market in late 2017—but it will surely be the biggest. Cialis pulled in $2.3 billion in sales last year. That figure could plummet to $55 million by 2022, estimates life science intelligence firm Evaluate. Several other generics makers are teeing up their versions of Cialis to launch after Teva’s exclusivity period ends, including Aurobindo, Watson and Sun Pharma.

Lilly did its best to hold on to Cialis, which accounted for 10% of its total revenue in 2017 and was its second-biggest seller after diabetes drug Humalog. In July of last year, the company reached a patent settlement that extended its Cialis exclusivity by nine months. The original dispute had involved a unit dose patent that was to expire in 2020. But now, Lilly’s legal options have run out on the storied ED drug.

If Cialis leaves any legacy, it could very well be those ubiquitous commercials. The first TV spot for the drug debuted during the 2003 Super Bowl, and it featured a man and woman in separate bathtubs on a beach, gazing out at the surf. Later ads relocated the couple to other outdoor locales—mountaintops, lakes and the like.

The ads may have been widely parodied, but for Lilly, they sent an important message: Cialis is different from Viagra and other drugs in the ED class because it has a time-release formula that allows men to take it anywhere up to 36 hours before they need it. The bathtubs were meant to evoke the idea of relaxation and the freedom for men to choose when they take the drug, a Lilly executive told FiercePharma in 2015.

It worked—so well, in fact, that the bathtub couples became a key graphic element of several Cialis marketing pieces. And Cialis routinely pushed Lilly to the top of ad-spending rankings. In 2014, for example, the company spent $272 million on Cialis ads, making the product the most advertiseddrug of the year, according to Kantar Media.

The loss of Cialis comes during a major time of transformation for Lilly. During its second-quarter earnings report in July, the company announced that it will spin off its animal health unit, Elanco, so it can pour more resources into its human pharmaceuticals business. The news was welcomed by investors, who'd been fretting over ongoing pricing pressure that could limit growth in Lilly’s diabetes unit.

In a stroke of lucky timing, Lilly did score a key FDA approval on the same day it faced the loss of Cialis. Thursday, the FDA approved the company’s migraine-prevention drug, Emgality, part of a new class known as CGRP inhibitors. Lilly is going all-out to get its product in the hands of patients, dispatching samples to physicians and offering 12 months of the product for free. The drug is expected to hit $700 million in sales by 2022, analysts estimate.

Lilly may need a Cialis-like marketing push for Emgality, considering it doesn’t have first-to-market advantage in CGRP. Amgen nabbed an approval for its migraine med, Aimovig, in May. Lilly’s other migraine rival? It’s none other than Teva, which got the FDA nod for its CGRP inhibitor, Ajovy, earlier this month.


 
 
 
Patent Pending:   60/481641
 
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