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The next several months will witness a shakeup in the U.S. consumer market for erectile dysfunction drugs. Viagra, the first ED drug to hit the market back in 1998, will fight for market share against its first generic competition beginning in December 2017.
Eli Lilly and Company, which introduced Cialis to U.S consumers in 2003, faces the expiration of one of its patents on that drug in late 2017. It also holds additional patents on the drug that don’t expire until 2020. It is now engaged in litigation that, if successful, would recognize the 2020 expiration date as the operative one, thus postponing generic competition for a few more years.
Even if Lilly is successful in convincing the courts and the U.S. Patent Trial and Appeals Board that its patent protection on Cialis should continue until 2020, it will still be affected by the coming availability of cheaper generic versions of Viagra.
Both Belong to Same Drug Family
Both Viagra and Cialis are oral ED drugs that belong to a family of medications known collectively as PDE5 inhibitors, so-called for their ability to temporarily sideline the phosphodiesterase-5 enzyme that can interfere with optimal blood flow. For the vast majority of men with ED, it is insufficient blood flow to the penis that causes their impotence. By optimizing blood flow for periods ranging from 4 to 36 hours, these drugs allow men with ED of vascular origin to get and keep erections firm and long-lasting enough for sexual intercourse.
Cialis for use as needed, the first form of Lilly’s drug brought to market, stands apart from the other PDE5 inhibitors in its ability to improve blood flow for up to 36 hours. However, men who are now using Cialis could very well be tempted to switch to generic Viagra if the price differential were attractive enough. And it’s likely to be sufficiently attractive, if not immediately, then certainly a few months after the generics hit the market.
Generic Will Precede Patent Expiration
Ordinarily, generic copies of a brand-name drug are prohibited until the expiration of the patent on the drug. In a somewhat unusual arrangement, Teva Pharmaceuticals USA in late 2013 negotiated a licensing deal with Pfizer that will allow Teva to begin selling its generic version of the little blue pill in December 2017, more than two years before Pfizer’s patent expires in April 2020. Pfizer will continue to reap profits from selling its branded version of Viagra while also collecting royalties from Teva under this unique licensing agreement.
It’s customary for the first drugmaker to introduce a generic version of a brand-name drug to enjoy six months of market exclusivity before the floodgates open and other generic competitors join the fray. However, in the case of generic Viagra, it appears that Teva will face generic competition almost immediately from Mylan, another major player in generic drugs, based on an agreement struck between Pfizer and Mylan in the spring of 2015.
Levitra Patent to Expire in 2018?
Another player in the U.S. market for ED drugs, Bayer Healthcare, markets Levitra, a PDE5 inhibitor with a patent that is scheduled to expire in 2018. At least one generic manufacturer has already had its generic formulation of the drug — vardenafil hydrochloride — approved by the FDA, although it can’t begin marketing that generic until Levitra’s U.S. patent expires.
Pfizer, Lilly, Bayer Healthcare, and other pharmaceutical companies that have marketed brand-name ED drugs over the past couple of decades have chalked up sales worth billions of dollars over the years. However, the arrival of generic competition is likely to signal the start of a sharp downtrend in the revenues those companies derive from their ED drugs.
Brand-Name Sales to Plummet
In a recent FiercePharma.com article about pending patent expirations, associate editor Eric Sagonowsky cited an EvaluatePharma analysis showing that Lilly’s Cialis sales in the United States are likely to slide from $1.42 billion in 2016 to just $55 million in 2022. In their predictions for Pfizer’s U.S. sales of Viagra over the next few years, EvaluatePharma analysts predicted a drop from $1.15 billion in 2016 to only $188 million in 2022.
Shed no tears for the pharmaceutical giants that have raked in substantial profits from their sales of ED drugs since the late 1990s and early 2000s. While they now face a sharp downturn in their revenues from those drugs, consumers will be the big beneficiaries as generics gradually become available for all of the brand-name ED medications now on the market.
Generic Prices Not Yet Posted
None of the generic drugmakers have posted prices for their generic versions of these ED drugs, but they are likely to represent a significant savings over the prices that have been paid for the branded medications. The FDA estimates that generics on average cost 80 to 85 percent less than the brand-name drugs for which they substitute.
While nobody expects that the early generic formulations of ED drugs will be priced 80 to 85 percent less than their brand-name counterparts, they will nevertheless represent a much better bargain, and as time goes on and more generics enter the U.S. market, downward price pressure will increase and average prices will drop even further.
If you found this article interesting and would like to stay on top of the latest developments on the consumer health front, particularly those relevant to sexual health and function, check out our blog.
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