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"10 years!" Li Yichen, the head of Beijing Zhongtian Kangda Pharmaceutical Technology Co., Ltd., was impressed. "The people who had been with us to form a lawsuit against the "Viagra" patent are already gone. Now the 'Viagra' patent protection is about to be When it expires, of course we have to produce it."
It is reported that "Viagra" currently has annual global sales of about 2 billion US dollars, and has made a lot of profits for Pfizer over the years. With the expiration of the patent, "Viagra" not only faces fierce competition from Bayer and Eli Lilly's related products, but also faces Chinese generic drug manufacturers who have previously filed lawsuits with them, as well as generic drug companies in countries such as Israel and India. competition.
The industry generally believes that as soon as the end of next year, there will be generic drugs in the domestic market. Therefore, Pfizer’s “Viagra†will at least be forced to cut prices by half to cope with it. In the face of generic drug melee, what is the “Viagra�
"Viagra" expires It is reported that in the European market, Pfizer's "Viagra" patent protection period expires on June 23, and many pharmaceutical companies will immediately launch similar drugs containing sildenafil. In this regard, Pfizer first started to be strong, will launch the economic version of "Viagra" recently, its price has dropped significantly from the current 10.30 ~ 14.96 euros to 2.08 ~ 6.25 euros.
The European market patent expires, is the Chinese patent the same? Xi Qing, a spokesperson for Pfizer China, acknowledged this claim. He said that the patent of "Viagra" in the Chinese market will expire in July next year, but the patent of "Viagra" in the United States will not expire until 2019.
Regarding whether it will respond to price cuts, Xi Qing also denied it. He said that it is not necessary for patent-expired drugs to directly cut prices, because it depends on the market demand environment, and for the launch of the new version of "Viagra" in Europe, Xi Qing It means that China and Europe belong to different business divisions, and their plans are different.
Since the acquisition of the patent of "Viagra" in China in 2001, it has occupied an absolute dominance in the field of medical treatment. According to Jiang Hui, the deputy director of the Chinese Medical Association's male science branch, the current market size of ED (male erectile dysfunction) in China is about 800 million to 900 million yuan per year, and the contract value of "Viagra" is shown. Its market share is more than half, roughly 500 million yuan.
According to the reporter's understanding, in general, if a company's generic drugs are to be sold to the market, they must first apply for clinical approvals and then conduct clinical trials. These procedures take time.
"But the 'Viagra' situation is different, generic drugs will appear soon." Li Yichen told reporters. Why will the generic drug appear in China in just a few months after the expiration of the "Viagra" patent in July next year? This is to start with the experience of "Viagra" in China. The experience of "Viagra" in China can be described as twists and turns.
In 1998, “Viagra†was officially put on the market in the world. However, the State Intellectual Property Office of China approved its patent rights on September 19, 2001. The result of the agreement was that the patent protection was as of July 2014. This shows that during the patent protection period after September 19, 2001, the production of “Viagra†by any domestic enterprise is an infringement.
Therefore, the patent case of "Viagra" in China has been opposed by many domestic "Viagra" imitations. On July 5, 2004, 12 Chinese pharmaceutical companies formed an alliance and applied to the State Intellectual Property Office for invalidation of the “Viagra†patent. The State Intellectual Property Office announced on the same day that the "Viagra" use patent of Pfizer Pharmaceuticals of the United States was invalid, and Chinese companies could produce "Viagra" by themselves.
But two years later, in June 2006, under the full lobbying and rebuttal of Pfizer, the Beijing No. 1 Intermediate People’s Court ruled that the State Intellectual Property Office had previously announced that the reason for the invalidity of the “Viagra†patent was not established, which means that Pfizer’s “salty The fish turned over and obtained patent protection for the products of Viagra.
"However, considering the early investment of domestic enterprises in the 'Viagra' drugs, it also considers that the patent of 'Viagra' will expire in the future. At that time, the State Food and Drug Administration did not recover the clinical approvals of 12 enterprises, and, These clinical approvals also do not have a deadline." Li Yichen said that the move means that the clinical approvals obtained by the company are effective for a long time, as long as the company is willing to conduct clinical trials at any time, which reduces the time for applying for clinical approvals, so next July. After that, generic drugs will quickly appear on the market.
Ten-faced ambush Although the patent has not expired, "Viagra" has already fallen into a scuffle between the giants.
After the listing of "Viagra", its competitors' similar products were also listed in a few years. Bayer's Elite was approved for listing in China in September 2004, and Eli Lilly was approved in June 2005.
According to Jiang Hui, the deputy director of the Chinese Medical Association's male science branch, in the entire ED drug treatment market of 800 million to 900 million yuan, in addition to "Viagra" with more than half of the amount of more than 500 million yuan in the market, Aili sales amounted to 300 million yuan, and Elite's annual sales amounted to tens of millions of yuan.
In the first quarter of this year, the financial report showed that Eli Lilly's global sales have surpassed Viagra for the first time. In the first quarter, Xi'ai's global sales were US$515 million (up 11% compared to 2012), while Viagra's global sales were nearly US$500 million (down 7% year-on-year).
According to data from Guangzhou Punctuation Medical Information Co., Ltd., although Pfizer is still occupying more than 50% of the ED chemical market in the north, it has maintained growth in Beijing and Shanghai, especially in Shanghai.
Domestic Baiyunshan Pharmaceutical, Jiangsu Lianhuan Pharmaceutical, Sichuan Yuanji Pharmaceutical, Zhuhai Biochemical Pharmaceutical, Beijing Zhongtian Kangda Pharmaceutical, Guangdong Biochemical Pharmaceutical Engineering Technology Development Center have already been eyeing this market. Millions, and more than tens of millions of similar drugs for the "Viagra" research and development.
Li Yichen said that if the above-mentioned enterprises are willing to conduct clinical trials in advance, they can submit the test materials to the SFDA in time when the "Viagra" patent expires next year, waiting for approval, so that the time-to-market for generic drugs will be greatly advanced, the fastest next year. You can enter the market in half a year.
This will also have a greater impact on "Viagra". Jiang Hui believes that, according to the entire men's group, the proportion of ED patients in China is roughly between 15% and 16%. Among the 1.3 billion people in China, men account for about 600 million, and according to this total, male ED patients may exceed 100 million. Based on this calculation, the domestic male sexual dysfunction market will not be less than 100 billion yuan.
According to Jiang Hui, according to this figure, the market size of the three preferred drugs such as “Viagra†in the ED market is less than 1%. “The main reason is that the price is too expensive. If the domestic generic drugs appear, and the drug prices are greatly reduced, this The market will expand rapidly."
Jiang Hui believes that the price of "Viagra" should be reduced by at least half. Xi'aili and Elida should also be like this because these drugs are chemical products and the production cost is not high. "I once suggested to the NDRC, but because 'Viagra' is not a medical insurance drug, the NDRC said it has no right to ask for it." A medical person said that a "Viagra" retail retailer 128 yuan, 10 packs of 965 yuan, a piece of nearly 100 Yuan, under the protection of patents, Pfizer, which has a high profit, has had a happy time in China for 10 years. Once the patent expires, the price of generic drugs of domestic pharmaceutical companies will fall below at least half of the price of Viagra. This will allow Pfizer to face more brutal competition than the two previous competitors. "There is still a year when Pfizer is ready to make a change."
Patent protection will expire, Chinese pharmaceutical companies robbed "Viagra"
As the fist product of Pfizer Inc., the patent protection of Wan Aike (commonly known as “Viagraâ€) in many markets around the world is about to expire. Pfizer China’s spokesperson Xi Qing told China Business Daily that “Viagra†is a patent in China. It will expire in July next year.