Brand Name Drug Companies Four Times as Likely to Reformulate Blockbuster Products to Extend Market Exclusivity

In case you missed it, a recent study published in JAMA Health Forum examines Big Pharma company applications for new formulations for prescription drugs approved by the U.S. Food and Drug Administration (FDA) from 1996 to 2010. New formulations represent changes to an approved drug including aspects such as “changes in delivery mechanisms,” “decreas[ing] dosing frequency,” “slight chemical alterations,” and changing “combinations of multiple active ingredients.”

The study found brand name drug companies target products that generate major profits for reformulation to extend monopoly pricing power and block generic competition from entering the market.

The results of the study show that “of 206 brand-name drugs approved in tablet or capsule form by the U.S. Food and Drug Administration between 1995 and 2010, approval of new formulations was four times more likely among blockbuster drugs,” defined as prescription drugs with annual sales of $1 billion or greater. The study also found that drug makers sought to pursue new formulations, “less frequently once generic competitors entered the market.”

The study’s conclusion argues that “revenue is a substantial driver of whether and when a manufacturer secures FDA approval of the first new formulation of existing drugs, reinforcing concerns that manufacturers are using evergreening strategies to maintain revenue and avoid generic competition.”

The study notes that oftentimes new formulations “may not be clinically superior to the novel drug, and their potential convenience benefits may be outweighed by their cost.”

Read the entire study, “Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021,” in JAMA Health Forum HERE.

Learn more about how Big Pharma’s price hikes don’t align with increased value for patients HERE.

Learn more about the cost of Big Pharma’s patent abuse HERE.

Learn more about market-based solutions to hold Big Pharma accountable and lower drug prices HERE.

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