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Table 4 Exclusivity for the first generic market entrant

From: Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States

  United States Canada Australia South Korea
Small molecules Biologics
Requirements for exclusivity be the first ANDA applicant arguing paragraph IV N/A N/A (1) the first ANDA that has challenged a patent and obtained a favorable decision; or
(2) the first ANDA that has filed a challenge within 14 days of the first challenge and has become the first to obtain a favorable decision
(3) filed a challenge within 14 days of the first challenge and become the first to obtain a favourable decision
Specific measures 180-day exclusivity N/A N/A N/A 9-month exclusivity, additional 2-month period is available to compensate for delayed marketing due to the reimbursement process
A starting point of the measures the date of the first commercial marketing N/A N/A N/A the date of the marketing