Debnath Bikash, Al-Mawsawi Laith Q, Neamati Nouri
Department of Pharmacology and Pharmaceutical Sciences, School of Pharmacy, University of Southern California, Los Angeles, California 90089, USA.
Drug News Perspect. 2010 Dec;23(10):670-84. doi: 10.1358/dnp.2010.23.10.1506088.
For the last two decades, we have seen remarkable growth in the pharmaceutical industry. This growth has mainly been due to the approximately 100 new blockbuster drugs, such as Lipitor® (atorvastatin) and Plavix® (clopidogrel). More than half of the revenue of major pharmaceutical companies and above one-third of the total pharmaceutical revenues came from the sales of these blockbuster drugs. Questions concerning the fate of these blockbuster drugs are beginning to surface as they are approaching their patent expiration dates, and as they are expected to face significant competition from generic versions. Branded drugs with more than USD 120 billion in sales (as of 2008) are expected to lose their patent protection in the next 3 to 4 years, while the less expensive generic versions are ready to enter the market. It is plausible that a major paradigm shift in our thinking is needed to stay innovative, competitive and economically feasible in this new era of drug development. A new wave of innovations is expected to boost the blockbuster regime. Herein, we discuss the different threats facing the branded monopoly, as well as some of the hopeful expectations for the blockbuster drug.
在过去二十年里，我们见证了制药行业的显著增长。这种增长主要归功于约100种新型重磅炸弹药物，如立普妥（阿托伐他汀）和波立维（氯吡格雷）。大型制药公司一半以上的收入以及整个制药行业总收入的三分之一以上都来自这些重磅炸弹药物的销售。随着这些重磅炸弹药物临近专利到期日，并且预计将面临来自仿制药的激烈竞争，有关它们命运的问题开始浮现。销售额超过1200亿美元（截至2008年）的品牌药预计将在未来三到四年内失去专利保护，而价格较低的仿制药已准备好进入市场。在这个药物研发的新时代，要保持创新、竞争力和经济可行性，我们的思维方式很可能需要发生重大转变。预计新一轮创新将推动重磅炸弹模式。在此，我们讨论品牌垄断面临的不同威胁，以及对重磅炸弹药物的一些乐观期望。
