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Generally speaking, in the European and American markets, after the patent expires, due to the swarming of generic drugs, most of the original manufacturers' drug sales market will decline rapidly. For example, Pfizer's super heavy drug Lipitor sold more than $10 billion for seven consecutive years from 2004 to 2010. After the patent expired, sales in 2013 were only $2.315 billion, and it has since fallen out of the global best-selling drug TOP25 list. .
Although the drug has suffered setbacks in developed countries such as Europe and the United States after the expiration of the patent, the benefits of the original research enterprises in the early developing countries are very impressive. Taking the domestic market as an example, although some of the original research drugs have been outdated for many years, the sales market in China is still doing well, making the domestic counterparts envious. By analyzing the sales data of the intranet drug, it was found that most of these original drugs were sold in key areas such as digestive system and cardiovascular system. In this article, based on the annual sales of 2 billion, the author will make a summary of the drugs that have a 50% share of foreign companies' sales, and analyze the preferences of foreign companies and our gaps.
1, clopidogrel
Category: Antithrombotic drugs
Annual sales: >6 billion
Business and share: Sanofi, 66%
Clopidogrel, trade name "Polivi", was approved by Bristol-Myers Squibb in 1997 and was marketed by Squibb and Sanofi. Prior to the expiration of the 2012 patent, Plavix became the world's second best-selling drug after years of Lipitor. After the expiration of the patent, the global imitation boom has been triggered. In China, companies such as Xinlitai have copied the drug. As domestic products become more mature, the market share has also increased year by year.
2, atorvastatin, rosuvastatin
Category: lipid-lowering drugs
Business and share:
Atorvastatin, the trade name "Lipitor", is Pfizer's best-selling drug and the first drug in the history of medicine to break through the $100 billion mark. It has sold more than $10 billion in seven consecutive years. . When the drug was approved in 1996, no one predicted that the drug would become the world's first prescription drug. Although its patents have expired after 2011, Yuwei still exists in developing countries.
Rosuvastatin was approved by the FDA in 2003. The trade name is “can be determinedâ€. It is another heavyweight lipid-lowering drug after Lipitor. In recent years, sales have exceeded $5 billion in consecutive years. Due to its patents, it is in the United States. There are several companies that have fought patents with the original research institutes. In any case, the patents of their compounds will expire this year, and the follow-up effect will wait and see.
3. Human albumin
Category: Plasma substitutes
Annual sales: > 4 billion
Enterprise and share: Jeter Bellin + Baxter + Gilliford, 65%
Human albumin, also known as serum albumin, is a sterilized pyrogen-free serum albumin product obtained from healthy donors. It is widely used in the treatment of shock caused by blood loss, trauma and burns, prevention and treatment of hypoproteinemia and edema or ascites caused by cirrhosis or nephropathy. Although domestic bioengineering technology has made great progress in recent years, in the competition with foreign companies, the progress is relatively slow.
4, cefuroxime, cefoperazone sodium sulbactam, imipenem cilastatin sodium, moxifloxacin
Category: Antibacterials
Business and share:
Cefuroxime is a second-generation cephalosporin, which is characterized by stable penicillinase and broad-spectrum β-lactamase, and is clinically used for respiratory diseases, ENT infections, etc. At present, the domestic market is dominated by “Ming Kexin†produced by the Italian company Esseti.
Cefoperazone sodium and sulbactam sodium are the third-generation cephalosporins, which are characterized by synergistic antibacterial action between cefoperazone sodium and sulbactam, which greatly enhances the antibacterial activity. There are many approvals for cefoperazone/sulbactam in China, and Pfizer's advantage comes from its bidding price.
Imipenem cilastatin sodium belongs to the carbapenem antibiotic, which is a combination preparation of a thiomycin thiol derivative and a renal deoxypeptidase inhibitor. The synergistic effect can kill most common Gram-positive and Gram-negative aerobic and anaerobic pathogens. Merck's product "Tai Neng" has saved the lives of countless patients. Although its US patents have declined in September 2009, the global market has declined, but domestic sales are less affected by patent expiration.
Moxifloxacin belongs to the class of fluoroquinolone antibiotics and has broad-spectrum antibacterial activity. Bayer's product “Bai Fu Le†is a new molecular entity approved by the FDA in 1999. With the expiration of domestic and foreign compound patents, Nanjing Youke and Chengdu Tiantai Mountain have obtained preparation approvals in 2013, and the market expansion will take time. day.
5, acarbose, mixed recombinant human insulin
Category: Diabetes
Business and share:
Acarbose is a product of Bayer, which is an α-glucosidase inhibitor. It has a general reaction in the European and American markets, but it has been unprecedented in the Chinese market and ranked first in the domestic diabetes market for many years. The reason may be related to eating habits. Studies have found that acarbose mainly reduces postprandial hyperglycemia. If the user's diet contains more than 50% carbohydrates, the hypoglycemic effect is more obvious. Therefore, acarbose is suitable for people who eat carbohydrates. The market has been dominated by Bayer for many years. Domestically, Hangzhou Zhongmei East China and Sichuan Green Leaf Baoguang produce tablets, chewable tablets and capsules.
Mixed recombinant human insulin, currently Novo Nordisk has domestic biosynthesis human insulin, protamine biosynthesis human insulin, protamine biosynthesis human insulin (premixed 50R, premixed 30R) and many other approvals. Novo Nordisk is a world-class leader in diabetes research and drug development, with the broadest range of diabetes treatment products, with insulin delivery systems known worldwide. Its annual report shows that the company's diabetes drug growth rate is the fastest, and the fastest growing regions are North America and China. The company predicts that its global market growth will be 7.6% in China from 2016 to 2020, which is higher than 6.8% in the US. Therefore, it is not surprising that its protamine biosynthesis human insulin (premixed 50R, premixed 30R) has a domestic market share of over 50%.
6, entecavir
Category: Antiviral drugs
Annual sales: >3 billion
Enterprise and share: Bristol-Myers Squibb, 56%
Entecavir is a cyclopentylguanine nucleoside analogue that is clinically the main treatment for chronic adult hepatitis B. Entecavir was a new molecular entity approved by Squibb in FDA in 2005. In August 2014, Teva was the first to receive a generic approval. Entecavir was brought into the domestic market by Sino-US Shanghai Squibb in 2005. Although there are dozens of companies producing it, Squibb's market share is over half, and Zhengda Tianqing is closely following.
7, budesonide
Category: Anti-asthma drugs
Annual sales: >3 billion
Business and share: AstraZeneca, 99%
Budesonide is a glucocorticoid anti-asthma drug that has been the leader in domestic anti-asthmatic drugs for many years. Budesonide was approved by the FDA in 1994. It is a meritorious drug of AstraZeneca. In recent years, its compound preparation with Formoterol, "Xinbi" is a member of the world's best-selling drug TOP25. At present, AstraZeneca's budesonide products have the approval of four dosage forms of aerosol, powder, nasal spray and inhalation suspension in China, and there are two kinds of Shanghai Xinyi, Lunan Bate only gas The aerosol approval, the domestic market is completely dominated by AstraZeneca.
8. Amlodipine
Category: calcium channel blockers
Annual sales: > 2 billion
Business and share: Pfizer, 77%
Amlodipine belongs to the class of dihydropyridines and is clinically used for anti-angina and hypertension. Amlodipine besylate is a product of Pfizer, trade name "Luohuxi", a new molecular entity approved by the FDA in 1992. Because clinical trials have proven that its long-term use in patients with coronary heart disease can significantly reduce cardiovascular events, it has become a leader in such therapeutic drugs. Although the patent of “Luohuxi†has long expired, and many companies in China have produced the product, it has not impacted the share of the original drug.
9, propofol
Category: Anesthesia
Annual sales: > 2 billion
Business and share: Corden, 57%
Propofol is an intravenous anesthetic that produces intravenous hypnosis through GABA in the central nervous system. Propofol is a new molecular entity approved by the FDA in 1989, and several companies in the country currently produce it. Propofol has been a commonly used anesthetic in the market and has been at the top of the list of such drugs for many years. The sales of its long-acting formulation propofol medium/long-chain fat milk also showed rapid growth, but the concentration was higher.
Comprehensive analysis of the above-mentioned drugs that are extremely popular in China, found that although foreign companies have layout in many fields, but outstanding achievements in the fields of digestive system, cardiovascular system and anti-infection, these are also areas of strong domestic sales. For example, in the treatment of diabetes drugs, China has the largest diabetes group in the world, and foreign companies have also laid out early. From the annual reports of major companies, we can pay attention to the Chinese market. They are not only constantly developing new drugs, but also increasing research and development efforts in the treatment system for diabetes. For example, in the insulin delivery system, in order to avoid the fear of needles, the development of Novo pen partners, disposable insulin injection pens, etc.; An insulin pump developed to achieve optimal control of blood glucose; an insulin delivery and blood glucose meter integration system developed to accurately monitor blood glucose levels. Not only that, in pursuit of safety and basically painless, the needle material and processing are refined to create a finer needle to increase patient compliance. Therefore, while ensuring the good curative effect of the product, the patient's comfort is continuously improved, thereby winning the favor of the majority of doctors and patients.
For individual drugs, many products have been or are still members of the global best-selling drug list. Although some drug patents have expired, the global influence is still not to be underestimated. In the process of market rushing, with its excellent quality. , curative effect and word of mouth, won the recognition of the market, it is worth learning.
