Fifteen years after Pfizer Inc.’s Viagra changed the sexual equation for older men, the blockbuster impotence drug is set to become available in a less expensive generic form as early as 2017.
Pfizer’s little blue pills, which generally cost about $15 each, replaced treatment that included penile injections, pumps and surgery. It will be produced generically, probably for a far lower cost, after Israel-based Teva Pharmaceuticals Industries Ltd. reached a legal settlement to sell a copy of the drug, whose chemical name is sildenafil citrate, more than two years earlier than expected.
More than 18 million Americans older than age 20 suffer from erectile dysfunction, according to Johns Hopkins University’s Bloomberg School of Public Health. Viagra, the first of three medicines to take on the issue, has been one of the best-known pills sold by Pfizer, the world’s biggest drugmaker, generating $2.05 billion in 2012, the most ever.
“This blue pill changed the way we practiced medicine,” said David Samadi, the chairman of urology at New York’s Lenox Hill Hospital.
The impotence-drug category includes Eli Lilly and Co.’s Cialis and Bayer AG’s Levitra. Indianapolis-based Lilly projects generic Cialis will enter the market in November 2017, though it has other patents on the medicine that last through 2020. Lilly attributed almost $2 billion in revenue to Cialis in 2012 alone.
Bayer’s main patent on Levitra expires in October 2018.
This year, Pfizer began selling the blue pill through a company-sponsored website to combat counterfeit versions sold online. Under a settlement announced yesterday, Teva, the world’s largest generic-drug maker, can enter the market on Dec. 11, 2017, and will pay patent royalties through the expiration of the Viagra patent in April 2020, New York-based Pfizer said in a statement. Other terms weren’t disclosed, and Teva already sells generic versions of the drug in some European countries.
Viagra was an accident. Pfizer first started looking at sildenafil citrate to treat high blood pressure and angina. During testing, though, patients developed erections. The patent, issued in 2002, is for use of the compound to treat impotence.
Some aspects of Viagra’s patent were earlier rejected in 2010 because it was similar to a Chinese herb known as Horny Goat Weed. Teva lost its bid to invalidate the rest of the patent at trial, and was appealing the case. The U.S. Court of Appeals for the Federal Circuit yesterday dismissed the appeals.
Erectile dysfunction gets more common as men age. It can also be caused by cardiovascular problems and a lack of physical activity.
After it was approved in 1998, Pfizer said 3 million patients got the drug that year, moving 50 million pills for $788 million that year, and $1.03 billion in 1999.
It had a particular allure in society, as patients had to pay for the drug themselves as insurance companies rarely covered it, said Louis Kavoussi, chairman of urology at Hofstra University’s Arthur Smith Institute for Urology in New Hyde Park, New York.
“That gave it more of an aura,” Kavoussi said in a telephone interview. “When patients came in, they’d beat around the bush, and you knew what they were asking for. It was like they were asking for the Playboy magazine in the back of the store.”
A generic version should cut the cost of the pills. “Going generic is a good thing; it’s very expensive,” Kavoussi said. “It is still not covered most of the time.”
That price, and the interest in the drug, has also prompted theft and counterfeiting. When Kavoussi changed offices in 2006, a demolition crew took apart the old space, he said. When they did, they found box after empty box of Viagra samples.
“They left them in the ceiling -- years later we found them!” Somebody -- likely hospital staff, Kavoussi said -- had been breaking into the supply closet, taking the pills and hiding the empties.
That aside, it was a revolution in treatment, said the two doctors. Many patients with sexual dysfunction were diabetics, whose disease had damaged blood vessels, hurting the ability of the penis to fill with blood to create an erection.
Others were prostate cancer surgery patients, a side effect of which can be the inability to become erect. For the prostate cancer patients, the potential of Viagra to help was particularly meaningful, Samadi said, since their average age in his practice was about 50.
“These are very young guys,” he said. “Viagra can be very successful in restoring function.”
Now about 70 percent of patients can be treated with pills, Samadi said.