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J Manag Care Spec Pharm. 2019 Feb;25(2):218-224. doi: 10.18553/jmcp.2019.25.2.218.

New Drug Formulations and Their Respective Generic Entry Dates.

Author information

1
1 Program On Regulation, Therapeutics, And Law (PORTAL), and Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts, and Department of Community Health Sciences, Cumming School of Medicine and O'Brien Institute for Public Health, University of Calgary, Canada.
2
2 Program On Regulation, Therapeutics, And Law (PORTAL) and Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts.

Abstract

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.

PMID:
30698097
DOI:
10.18553/jmcp.2019.25.2.218
[Indexed for MEDLINE]
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