Celebrex, the listed proprietary medicine developed by Pfizer, is the worldbrand medicine for anti-inflammatory and analgesic with the largest prescription sales volume and the annual sales revenue of approximate 2.4 billion US dollars. The drug patent will be expired in 2015.

The production application of drug substance and capsule of Celecoxib, generic drugs of Celebrex, have been accepted into the review of the state in June, the information revealed by SFDA. In China, there are five pharmaceutical enterprises including Hisun Pharmaceutical, Hengrui Medicine and other three pharmaceutical enterprises come into the fierce competition to get the first generics.

The pharmaceutical enterprises with patent medicines can enjoy franchise of patent medicines for 20 years to protect their benefits due to huge investment, difficulties and long cycle returns of the original drug research. Other pharmaceutical enterprises can’t produce the product until patent protection expires.

Since the prices of the generics usually vary from one fifth to one tenth of that of the patented brand drugs, many enterprises will inevitably be attracted by the patent manufacturers market to get the generics with their absolute price advantage and better quality standards to gain profits.

From 2010 to 2017, drugs of worthing 150 billion US dollars were and will be beyond patent protection, which promotes the generics market to grow from 123.85 billion US Dollars in 2010 to 231 billion US Dollars in 2017, the information released by Global Generics Market Analysis Report. As the world\'s largest generics market, China meets great opportunities.

Hubei Pharmaceutical Enterprises Striving for Getting First Generics in China

It is the first generic drugs that really get a huge profit. Imitation followed by the first generic drugs will get less.

The so-called first generics in China means "first studying and applying drugs that have been listed in foreign countries while unlisted in China". In accordance with Chinese relevant policies to encourage pharmaceutical development, the first generics will enjoy the separate pricing right at domestic markets.

How much profits of the first generics are?

The medication data from the sampled hospitals in 22 domestic cities showed that in 2011 the medication amount of China\'s 10 leading generics reached 7.81 billion RMB, increasing by the average rate of about 20 percent.

Aiming at the market with painstaking research and development, Hubei pharmaceutical enterprises have made initial achievements to get China\'s first generics.

As early as 2005, Remifentanil Hydrochloride for Injection developed by Humanwell Medicine Group was reported on the success to get the first generics. Humanwell Medicine Research Institute built in 2008 helped increase the amount of the first generics. Up to now, Humanwell Medicine Group has successfully applied over ten first generic drugs.

Incorporating many multinational pharmaceutical R & D personnel from the United States, Canada, India and other countries, Grand Pharmaceutical Group seized the first generics market by means of the independent research and development and exclusive overseas authorization, thus eight first generics having been successfully applied.

HEC Pharm Group in Yichang established R&D Institute and employed more than 30 technical experts used to work in international renowned pharmaceutical enterprises to attach most importance to the high-end generic drugs. At present, more than 10 first generic drug projects are in the development and approval stage and the products are expected to market in recent years."R & D of the first generics generally require from one to three years and the application cycle for about two years. There are two important things for the first generic drugs: increasing research and development and good projects aimed at targeting the market." said Wang Xuehai, Chairman of Humanwell Pharmaceutical Group Corporation. The get-up-early bird can get the food to eat, and even pick something nice.

To get the first international generics, is it enough in10 years or 5 years?

With the definition of the first generic drugs, there is another story in the United States.

The first generics applicant will have market exclusivity right for 180 days in case of "patent is invalid or the medicine applied for approval will not infringe the patent". The market here indicates the international market.

Wang Xuehai makes an analogy that some international first generic drug can be sold for about 60 US dollars if 100 US dollars sold for the patent drug.

Although incapabilities to get the international first generics due to limited certification, R & D capabilities and sales channels, the domestic pharmaceutical enterprises still have a strong aspiration to get "60 US dollars".

As for preparation, it is the sooner the better.

There are more than 40 generic drugs in research and development stages, each one with the investment of 5 million US dollars. Therefore, Humanwell Medicine Group, with its R & D Base in the United States, has owned the largest number of generic drugs of the research and development in China.

"Humanwell Medicine has got the U.S. Food and Drug Administration (FDA) certification and the EU Certificate Of Suitability(COS) certification. Humanwell Medicine, with R & D base and cooperating agencies in the United States, is underway to be the first international generics enterprise within 10 years if overseas sales channels are available." Mr. Wang made the schedule for Humanwell Medicine to be the first.

In this regard, Zhu Qiaohong, Deputy General Manager in HEC Pharm Group, is even more optimistic."We luckily found the researcher of some patent medicine and invited him to guide the research and development of generics." he added that the enterprise would be expecting to be the first international generics enterprise in the five years if everything is OK and looking forward to having the globle patent medicine in the future.

Grand Pharmaceutical Group can do where some patent drugs are beyond the regulation of patent decree. Once opptunities are available, Grand Pharmaceutical Group has the possibility of making generics in advance. Yang Bo, Technical Director of Grand Pharmaceutical Group, said so.

From the point of patent game between the world\'s first generic drugs and the original drugs, the original manufacturer will usually raise barriers to entry through registering constantly related patents to maintain exclusive rights for products. Patent litigation has become a good strategy to keep exclusive rights for the market in case of the application and listing of generics.

In this regard, pharmaceutical executives said that overseas localization strategy of Hubei pharmaceutical enterprises should be taken of great significance and enterprises should take a stride to go global. (Reporter Zhang Qian)