On December 9, the US Handa Pharmaceuticals, Fosun Pharmaceutical Holdings, received US FDA’s official notification, its Release Quetiapine was the first domestic generic product produced by China pharmaceutical enterprise’s affiliated company obtained the formal FDA Tentative Approval.

It is known that Fosun Pharmaceutical invested HanDa Pharmaceuticals in 2009, and strongly supports HanDa Pharmaceuticals to develop generic drugs challenging patents in American and European markets. HanDa pharmaceuticals is a small US research and development enterprise, specializing in sustained release dosage forms technology and development of generic drugs challenging patents. Doctor Liu Yufang, the founder of HanDa Pharmaceuticals, has launched several such drugs in the past ten years. Generic drugs challenging patents refer to the similar drugs developed through technological innovation without patent infringement before the patent expire of the original brand, and use the P4 declare channel stipulated by US FDA, so as to break the monopoly of brand drugs and reduce the patients’ financial burden.

Doctor Liu Yufang said that in 1984, the United States enacted Hatch-Waxman Act bill, encourage generics manufacturing enterprises to challenge patent drugs, and enjoy the exclusivity of the market for 180 days for the first successful challenge. Therefore, obtaining the exclusivity of the market for 180 days becomes a diligently pursing goal to the excellent generics manufacturing enterprises with the technology innovation ability and knowledge of the patent. In 2006, we officially set up HanDa Pharmaceuticals, our advantage is specializing in sustained release dosage forms technology and development of generic drugs challenging patents.

Quetiapine is a new generation of products used to treat schizophrenia, bipolar mental disorder, anxiety and other kinds of psychiatric disease. Compared with the traditional drugs, quetiapine can treat more widely and obvious more effective to the negative symptoms than that of the traditional drugs, with high safety, less serious side effects, smaller dose, thus significantly improving patients’ compliance. The global sales of the immediate dissolving dosage form in 2008 already reached $4.9 billion, the new controlled release dosage form gradually replaced the immediate dissolving dosage form after its launch, in 2009, the sales of the controlled release dosage form was about $500 million and is expected to reach $1 billion this year.

HanDa Pharmaceuticals has been submitted the application of 5 doses generic drugs to the US FDA from 2008, including the first four generic drugs, and submitted the supplementary information in the following two years. The FDA’s prelicensing is based on that HanDa’s generics drugs application materials complying with the US FDA’s regulations, and the production and test facility of the drugs complying with cGMP’s regulations. Since the products are declared through the P4 channel, and they can obtain official permission once any one of the following three conditions is met: 1) 30 months of intellectual property lawsuit with counterpart manufacturers expired or 2) court decided HanDa’s products were non-infringement, or 3) counterparts products’ patents expired.

Cui Zhiping, vice president and general manager of Fosun Pharmaceutical said that generics, especially generics challenging patent had the vast market prospect, such as quetiapine, the first generic drugs of such a great variety, its profit could reach hundreds of millions of dollars. In fact, the research and development of difficult generic drugs is win-win to patients and pharmaceutical enterprises, because the high quality generic drugs can break the monopoly of brand drugs, and reduce the cost of treatment. The improved generic drugs can also enhance the treatment level.