Editorial | ONLINE FIRST

Evidence of Pharmaceutical Innovation and Therapeutic Enthusiasm:  Strategies for Patent Extension

Bruce M. Psaty, MD, PhD; Rita F. Redberg, MD, MSc
Arch Intern Med. 2012;172(9):683-684. doi:10.1001/archinternmed.2012.382.
Text Size: A A A
Published online


In this issue of the Archives, Downing et al1 present a case report about how a pharmaceutical manufacturer successfully avoided generic competition for one of its blockbuster drugs for more than a decade. The use of patent infringement lawsuits to delay generic competition, a practice called “evergreening,” is common and perhaps well known.

However, for fenofibrate, Abbott Laboratories devised a novel and especially clever approach: the manufacturer reformulated the drug at a slightly different dose, gained approval on the basis of claims of bioequivalence, and then avoided competition because the minor differences in dose prohibited generic substitution. In 2000, for instance, Abbott used efficacy and safety data from previously submitted clinical trials in its “new” drug application and, on the basis of the results of 4 small pharmacokinetic studies, claimed bioequivalence between the approved formulation (Tricor-1 capsules with 67-, 134-, and 200-mg doses) and the new formulation (Tricor-2 tablets with 54-mg and 160-mg doses). No new clinical trials of triglyceride lowering were conducted. In 2001, the manufacturer switched exclusively to sales of Tricor-2 tablets, so that patients taking fenofibrate had to be switched over to Tricor-2 doses during the 6 months before the generic versions of Tricor-1 doses were approved by the Food and Drug Administration. As a result of the minor change in dose, pharmacists filling Tricor-2 prescriptions could not substitute generic versions of Tricor-1 when they finally became available in early 2002, despite the fact that the manufacturer had won approval on the basis of pharmacokinetic evidence for bioequivalence. The manufacturer used these methods repeatedly to avoid generic competition through December 2011.

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

First Page Preview

View Large
First page PDF preview





Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).
Submit a Comment


Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 2

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

See Also...
Articles Related By Topic
Related Topics