With Pfizer’s Chinese patent for Viagra about to expire, Chinese drug manufacturers are lining up in the hopes of winning approval to market their versions of the “little blue bill” that has transformed the face of impotence treatment around the globe.
The entry into the market of low-priced generic versions of Viagra could significantly expand China’s overall market for erectile dysfunction drugs, which has heretofore been dominated by medications that are priced beyond the means of many Chinese consumers.
Viagra Dominated Market
Currently estimated at about 1 billion yuan (nearly $161 million), the Chinese market for ED drugs has been dominated by Pfizer’s Viagra, which up until now has had a 60 percent share. Other major p players in China’s impotence drug market are Eli Lilly’s Cialis, which accounts for 20 percent of all sales, and Bayer HealthCare’s Levitra, with a 10 percent share, according to TheStreet.com.
Guo Wei, a security analyst with market research company Ipsos, told ChinaDaily.com that he expects that Chinese pharmaceutical companies “will promote their versions of the ED product at a much lower price, less than half that of sildenafil,” Viagra’s active ingredient. With much lower prices, previously untapped portions of the potential Chinese market can be served.
Among the drugmakers hoping to market its generic version of Viagra is Jiangsu Lianhuan Pharmaceutical Group, which for years was locked in a battle over Pfizer’s patent rights.
Long-Running Patent Battle
In 1994, well before Pfizer won approval to market Viagra in the United States, the company had applied for a Chinese drug patent. In 2001, China’s State Intellectual Property Office finally approved Pfizer’s patent application.
What followed was years of legal wrangling between Pfizer and a handful of Chinese drugmakers, including Lianhuan, that Pfizer accused of patent infringement. A Chinese court ultimately upheld the validity of Pfizer’s Viagra patent, enjoining the Chinese companies from marketing their generic versions of the drug.
Competition Will Intensify
With the expiration of Pfizer’s patent in July 2014, competition in the lucrative Chinese market for impotence drugs is certain to intensify with the entry of several generic versions of Viagra. With lower prices set for generic versions of sildenafil, this drug’s share of the overall market is almost certain to expand, putting new pressure on Viagra’s top competitors, Cialis and Levitra.
According to China’s health ministry, chronic ED affects roughly 40 million Chinese men, many of whom have been unable to afford impotence drugs up until now. Chinese-made generic versions of sildenafil are expected to sell for as little as 25 percent of what Pfizer charged for Viagra.
South Korean Experience
Pfizer’s Viagra patent in South Korea expired in mid-2012. Although South Korea’s market for ED medications is only a fraction the size of China’s, what happened in South Korea may be an indication of what’s likely to happen in China. In the wake of Pfizer’s patent loss, more than 50 generic versions of the drug hit the market. By the end of 2013, Hanmi Pharmaceutical’s generic version — selling for a third the price of Viagra — had captured 45 percent of South Korea’s ED drug market, compared with 40 percent for Pfizer’s Viagra.
Adding insult to injury, at least in Pfizer’s view, Hanmi’s generic version is “almost a carbon-copy design, a blue diamond-like shape with round edges,” a Pfizer spokesman told “The Korea Times.”
Viagra Patent Expirations
Over the last couple of years, Pfizer’s patent for Viagra has expired in several key markets, including the European Union, where Pfizer’s patent expired in June 2013. Meanwhile, numerous generic versions of sildenafil have hit pharmacy shelves in Europe and the United Kingdom since the patent expiration.
In the first quarter of 2014, Pfizer’s international sales of Viagra totaled $374 million, down 19 percent from the same period in 2013. Pfizer’s worldwide sales of Viagra slipped from a 2012 total of $2.05 billion to $1.88 billion, according to FirstWord Pharma. The drop in Pfizer’s international sales allowed Cialis — with global sales of $2.16 billion — to become the best-selling ED drug worldwide in 2013.
Global Sales Slipping
So the loss of its Chinese patent in mid-2014 is expected to further cut into Pfizer’s international sales of Viagra for 2014 as a whole. According to WantChinaTimes.com, Viagra has been Pfizer’s most profitable drug on the Chinese market.
Back in the United States, where Pfizer’s patent for Viagra will not expire until 2017 or 2018, the little blue pill was still the top-selling ED drug in 2013, according to Medscape Medical News. Viagra’s U.S. sales totaled nearly $1.2 billion, compared with roughly $1.09 billion for Cialis. Based on these sales totals, research firm IMS Health said Viagra ranked 37th among the 100 best-selling U.S. prescription drugs in 2013. Not far behind was Cialis, which occupied 42nd place among the top 100.
Bid for OTC Viagra
Back in 2008, well in advance of its EU patent expiration, Pfizer applied to the European Medicines Agency for approval to market an over-the-counter version of Viagra in the European Union. The company withdrew its application after the EU drug agency voiced concern that allowing men to get the ED drug while bypassing checkups by medical professionals might result in serious medical problems going undiagnosed.
While withdrawing its application for OTC approval, Pfizer made it clear that it disagreed with the EMA. Pfizer said, “Millions of men in Europe are currently circumventing the healthcare system when seeking ED medicines, exposing themselves to unnecessary risks of medicines from uncontrolled sources and the missed opportunity to get important health information from a healthcare professional.”
Had Pfizer’s OTC version of Viagra been approved, the impact of the company’s loss of patent protection in the EU might have been somewhat minimized.
Viagra Was the First
Viagra, approved by the FDA in 1998, was the first of the new wave of impotence drugs to reach the market. Sildenafil citrate, Viagra’s active ingredient, is classified as a PDE5 inhibitor, so-called because it temporarily blocks the effects of an enzyme known as phosphodiesterase-5. The PDE5 enzyme can compromise strong blood flow to the penis, which is essential in order to get and maintain an erection hard enough for intercourse.
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Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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