New Drug Formulations and Their Respective Generic Entry Dates.

BACKGROUND

After new prescription drugs reach the market, manufacturers sometimes create modified versions of them. These new formulations can expand patient treatment options, but they may also be protected by later-expiring patents or data exclusivities, which can lead to later generic entry for the new formulations compared with the original product.

OBJECTIVE

To quantify how frequently manufacturers introduce new formulations of existing drugs and how often these new formulations earn additional years of market exclusivity beyond that of the original product.

METHODS

Using a cohort design and FDA databases, we assessed how frequently manufacturers introduced new formulations of 17 new small-molecule drugs approved in 2002 and when generic entry for the new formulations and original product occurred.

RESULTS

Through 2017, nine (53%) drugs approved in 2002 had been connected to 21 new formulations, most (11/21, 53%) introduced before 2007. Generic entry was observed in 6 of 9 (67%) cases and occurred more than 2 years later for the new formulations in 3 of the cases.

CONCLUSIONS

Our results suggest that the introduction of new formulations of brand-name drugs occurs in about half of cases and sometimes provides manufacturers with a lengthy period of additional market exclusivity beyond that of the original product.

DISCLOSURES

This work was funded by the Laura and John Arnold Foundation. Kesselheim and Sarpatwari also receive support from the Harvard-MIT Center for Regulatory Science and the Engelberg Foundation. Beall has nothing to disclose.