Which will be the Final Winner on the Market: Original Drugs or Generic Drugs? (2)

Ale VS Lipitor

The blood lipid regulating drugs are second only to the antineoplastic chemical drugs both on the Chinese and global markets. Statins account for about 90% share on the blood lipid regulating prescription drug market in China. According to relevant data, atorvastatin has become the leading variety on the Chinese blood lipid regulating drug market, and terminals like China’s city and county public hospitals and retail pharmacies account for 36% of the blood lipid regulating drug market in China.

The original drug of atorvastatin is Lipitor of Pfizer, which was marketed in 1997, and entered the Chinese market in 1999; also in 1999, Beijing Jialin’s "Ale", the first generic product of Lipitor in China, was marketed. 30% cheaper than Lipitor, Ale has broken the monopoly of the imported drug.

Pfizer’s Lipitor was still number one on the atorvastatin market of public hospitals of key cities in China in 2016, accounting for 76.09% market share, while Ale accounted for 18.59%, with Beijing, Guangzhou, Shanghai, Wuhan, and Chongqing being the main sales markets of atorvastatin. The total sales of Ale tablets reached RMB 3.9 billion in China in 2016.

CFDA approved Henan Topfond Pharma, Slovenia Lek, Guangdong Baike, Zhejiang Neo-Dankong, etc. to produce the relevant generic drug of Lipitor after expiration of the 8-year protection period of Ale in China.

Taijia VS Plavix

Plavix is the trade name of clopidogrel bisulfate, was co-developed by France Sanofi and U.S. Squibb in 1996 and approved for marketing by FDA in 1997, and entered the Chinese market in August 2001. Plavix is the pharmaceutical product with the second largest sales in the history of the world, second only to Pfizer’s lipid-lowering drug Lipitor. Its global sales approached USD 10 billion in 2011, however, its sales fell suddenly after 2012 as impacted by patent expiration and marketing of generic drugs, etc.

Taijia received China’s national Class II new drug certificate on September 1, 2000, and enjoyed an 8-year protection period. Taijia and Plavix have been the top two by share in the antithrombotic drug market in China as Taijia was approved for marketing before Plavix entered China, and Shuaixin, the second clopidogrel bisulfate generic drug in China, was not marketed until 2012.

Market Share of the Antithrombotic Drug Taijia in China in 2013-2016

Source: Sinohealth CMH

According to Sinohealth data, Plavix has been top 1 by market share in China for consecutive years, with the market share of 20%~30% in recent years, but showing a gradual decline trend. According to the data of hospital drug database of Xanda, the sales of Plavix were about RMB 1.1 billion, of Taijia were about RMB 545 million, and of Shuaixin of Lepu were about RMB 194 million in China in 2016.

Taijia passed the EU certification in January 2013 and is currently marketed in more than ten EU countries, in addition to the Chinese market. Taijia and Plavix have been carving up the clopidogrel bisulfate market in China, however, the clopidogrel bisulfate tablets of CSPC were accepted by CDE in March 2017 and are currently queuing for review, and CSPC is expected to become the fourth enterprise selling clopidogrel bisulfate tablets in China; furthermore, 82 enterprises including Yusheng Pharmaceutical, Hengrui Medicine, Zhejiang Medicine, and Luoxin Pharmaceutical are developing clopidogrel bisulfate tablets. The market space of the two giants may be eroded, as more and more generic products hit the market.

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