Table 4 Exclusivity for the first generic market entrant

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