Researchers Detail Evolving Challenges to Branded Drugs in Journal of Medical Economics Article

February 26, 2014

While the average market exclusivity period (MEP) for brand-name drugs -- the time between the launch of a new drug and the entry of its first generic competitor -- has remained relatively constant over the past 10--15 years, generic manufacturers are challenging the patents protecting brand-name drugs more often and earlier, according to an Analysis Group study by Senior Advisor Genia Long, Vice President Richard Mortimer, and affiliated expert Professor Henry Grabowski of Duke University, recently featured in the Journal of Medical Economics.

The article, "Recent Trends in Brand Name and Generic Drug Competition" (March 2014), found that for drugs experiencing initial generic entry in 2011--12, the MEP was 12.6 years for drugs with sales greater than $100 million (in 2008 dollars) in the year prior to generic entry, and 12.9 years overall. The Analysis Group team used research data from IMS Health National Sales Perspectives, government records, and public information for this study.

"Although the average market exclusivity period for brand-name drugs has remained fairly consistent over the past 10--15 years, the pattern of patent challenges has changed dramatically," said Ms. Long. "While only 9 percent of drugs experiencing initial generic entry in 1995 also experienced at least one Paragraph IV challenge from a generic manufacturer, over 80 percent of new molecular entities experiencing initial generic entry in 2011--12 did. Moreover, these challenges are now filed relatively early in the brand-name drug life cycle, or within seven years after brand launch, on average."

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