Estimating Costs of Market Exclusivity Extensions For 4 Top-Selling Prescription Drugs in the US

What is the excess US spending associated with delays in generic competition due to extended market exclusivity?In this retrospective serial cross-sectional analysis of 4 top-selling drugs (imatinib, glatiramer, celecoxib, and bimatoprost) including 5.7 million Medicare beneficiaries, extended market exclusivity beyond key patent expirations ranged from 7 to 13 months. This delay resulted in an estimated $3.5 billion in excess spending over a 2-year period, with $1.9 billion in commercial plans and $1.6 billion in Medicare.These findings indicate that policies promoting timely generic drug availability by limiting market exclusivity extensions could lead to substantial savings for US patients and payers.

Corresponding Author: Ameet Sarpatwari, PhD, JD, 1620 Tremont St, Ste 3030, Boston, MA (asarpatwari@hsph.harvard.edu).

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