Downing Nicholas S, Ross Joseph S, Jackevicius Cynthia A, Krumholz Harlan M
Yale University School of Medicine, New Haven, Connecticut, USA.
Arch Intern Med. 2012 May 14;172(9):724-30. doi: 10.1001/archinternmed.2012.187.
The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug's history: Abbott Laboratories, the maker of branded fenofibrate, has produced several bioequivalent reformulations that dominate the market, although generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on the US health care system. Abbott Laboratories maintained its dominance of the fenofibrate market in part through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first-generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented their substitution with generics of older-generation products. As soon as direct generic competition seemed likely at the new dose level, where substitution would be allowed, Abbott would launch another reformulation, and the cycle would repeat. Based on the fenofibrate example, our objective is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications, without demonstrating the superiority of next-generation products.
品牌非诺贝特的制造商雅培实验室已生产出几种生物等效的重新配方产品，这些产品主导着市场，尽管非诺贝特的仿制药已上市近十年。这种品牌配方产品的持续使用，其成本是非诺贝特仿制药的两倍，给美国医疗保健系统带来了每年约7亿美元的成本。雅培实验室维持其在非诺贝特市场的主导地位，部分是通过一种复杂的转换策略，包括相继推出未被证明优于第一代产品的品牌重新配方产品，以及通过专利诉讼来延迟仿制药配方的批准。较新品牌配方产品在剂量上的微小差异使得它们无法被老一代产品的仿制药替代。一旦在允许替代的新剂量水平上似乎可能出现直接的仿制药竞争，雅培就会推出另一种重新配方产品，如此循环往复。基于非诺贝特的例子，我们的目标是描述当前政策如何能让制药公司通过品牌药物的重新配方来维持市场份额，而无需证明下一代产品的优越性。
