*** Chinese monopoly will snatch end-finance companies

The happy time for “Viagra” in China’s patent monopoly is coming to an end.

As the flagship product of Viagra in the United States - Viagra (commonly known as "Viagra") patent protection in many markets around the world is about to expire, Pfizer China company spokesman Xi Qing told the "China Business" that "Viagra" patent in China It will expire in July next year.

"10 years!" Li Yichen, head of Beijing Zhongtian Kangda Medical Technology Co., Ltd., said with emotion that "someone who had been allied with us to sue for 'Viagra' patents was gone, and now 'Viagra' patent protection is about to At the end of the year, we certainly have to produce."

It is reported that "Viagra" currently has annual global sales of about 2 billion U.S. dollars. Over the years, it has made a lot of profit for Pfizer. With the expiration of the patent, "Viagra" faces not only the fierce competition between related products of Bayer and Eli Lilly, but also the Chinese generic drug manufacturers that had previously litigated with it, 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, the domestic market will have generic drugs launched, therefore, Pfizer's "Viagra" will be forced to cut prices at least half to deal with, in the face of generic drugs, "Viagra" where to go?

"Viagra" expires

It is reported that in the European market Pfizer's "Viagra" patent protection period expires on June 23, many pharmaceutical companies will immediately launch similar products containing sildenafil. In this regard, Pfizer has taken the lead and will launch the economic version of “Viagra” in recent days. Its price has dropped sharply from current 10.30 to 14.96 euros to 2.08 to 6.25 euros.

European market patent expires. Does China patent do the same? Pfizer China company spokesman Xi Qing acknowledged this claim. He said that the "Viagra" patent in the Chinese market will expire in July next year, but the US "Viagra" patent will not expire until after 2019.

In response to whether or not to deal with price cuts, Xi Qing also denied, he said, not necessarily patent expired drugs will directly cut prices, because it depends on the market demand environment, and for Europe to launch a new version of "Viagra", Xi Qing Said that China and Europe belong to different divisions and their plans are not the same.

Since the "Viagra" patent was sold in China in 2001, it once occupied an absolute dominant position in the field of drug treatment. According to the estimation of Jiang Hui, the chairman of the Chinese Medical Association's Male Science Section, the market size of regular ED (Male erectile dysfunction) in China is roughly 800-900 million yuan per year, and the prescription contract amount for 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 on 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 soon appear." Li Yichen told reporters. Why would a generic drug appear in just a few months after the expiration of the “Viagra” patent in July? This should be started from the experience of Viagra in China. The experience of Viagra in China can be described with twists and turns.

In 1998, "Viagra" was formally put on the market for the first time in the world. However, the State Intellectual Property Office of China approved its patent right on September 19, 2001. As a result of the agreement between the parties, the protection of patents ended in July 2014. This shows that during the patent protection period after September 19, 2001, any domestic company producing "Viagra" was infringed.

Therefore, the "Viagra" patent case in China was opposed by many "Viagra" copy makers in China. On July 5, 2004, 12 Chinese pharmaceutical companies formed a coalition and applied to the State Intellectual Property Office for "Viagra" patent invalid. The State Intellectual Property Office announced on the same day that the Pfizer pharmaceutical company's "Viagra" use patent was invalid, and Chinese companies could produce "Viagra" on their own.

However, two years later, in June 2006, under the full lobbying and refutation of Pfizer, the Beijing No. 1 Intermediate People’s Court ruled that the reason why the State Intellectual Property Office had previously declared the “Viagra” patent ineffective was not established, which means that Pfizer’s “salty "Fish turned over" and obtained patent protection for "Viagra" products.

"However, taking into account the initial investment of domestic companies in 'Viagra' drugs, but also taking into account the future 'Viagra' patent expires, then the State Food and Drug Administration did not recover the clinical approval of 12 companies, and, There are no deadlines for these clinical approvals.” Li Yichen said that this means that the clinical approvals obtained by the company are valid for a long period of time. As long as the company is willing to do so, clinical trials can be conducted at any time. This reduces the time for applying for clinical approvals. Therefore, July next year Afterwards, generic drugs will quickly appear in the market.

Ten ambush

Although the patent has not yet expired, "Viagra" has long been caught in a melee between giants.

After the listing of "Viagra", similar products of its competitors have also been listed several years later. Bayer Pharmaceutical's Erica was approved for listing in China in September 2004, and Lilly's Greek Alice was approved in June 2005.

According to Jiang Hui, the chairman of the Chinese Medical Association's male science division, it is estimated that in the entire ED drug treatment market, 800 million to 900 million yuan, in addition to the "Viagra" to occupy more than half of the market by more than half a billion yuan, Aili’s sales amounted to 300 million yuan, and Alecda’s annual sales amounted to tens of millions of yuan.

The financial report for the first quarter of this year shows that Eli Lilly’s global sales have surpassed Viagra for the first time. In the first quarter, Celia’s global sales were US$515 million (up 11% compared to 2012), and Viagra’s global sales were nearly US$500 million (down 7% year-on-year).

According to data from Guangzhou Puncak Pharmaceutical Information Co., Ltd., although Pfizer can still occupy more than 50% of the ED chemical market in the North, Guangzhou Lilly has maintained growth in Beijing and Shanghai, especially in Shanghai.

However, domestic companies such as Baiyunshan Pharmaceutical, Jiangsu Lianhua Pharmaceutical, Sichuan Yuanji Pharmaceutical, Zhuhai Biochemical Pharmaceutical, Beijing Zhongtian Kangda Pharmaceutical, and Guangdong Biochemical Pharmaceutical Engineering and Technology Development Center have long been eyeing this market. Millions, as many as tens of millions, develop R&D for similar drugs of Viagra.

Li Yichen stated that if any of the above companies are willing to carry out clinical trials in advance, they can submit test data to the SFDA in time for the next “Viagra” patent to expire, waiting for the approval to pass, so that the time to market for generic drugs will be greatly advanced, and the fastest next year will be. Six months can enter the market.

This will surely create 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% to 16%. Of the 1.3 billion people in China, about half of the men are male, and if this total is exceeded, the number of male ED patients may exceed 100 million. Based on this calculation, the market size of domestic male sexual dysfunction will not be less than 100 billion yuan.

Jiang Hui said that according to this figure, the market size of three preferred drugs such as “Viagra” in the ED market is still less than 1%. “The main reason is that the price is too expensive. If the domestic generic drugs appear, and lead to significant price reduction of drugs, this The market will expand rapidly."

Jiang Hui believes that the price of “Viagra” should be reduced by at least half, and Cili’s and Elita’s should also be the same, because these drugs are chemical products and their production costs are not high. "I once suggested to the NDRC, but because 'Viagra' is not a Medicare drug, the Development and Reform Commission said it has no right to request it." A person in the pharmaceutical industry said that a "Viagra" retails at 128 yuan, and 10 packs are at 965 yuan, a total of nearly 100. Yuan, under the protection of patents, Pfizer, which has a high profit, has spent 10 years of happy time in China. Once the patent expires, the price of generic drugs in domestic pharmaceutical companies will fall to at least half the price of “Viagra”. This will allow Pfizer to face more brutal competition than the two previous competitors. "One year later, Pfizer has come to make a change."