| METHOD |
(1) Patent has not expired, but applicant certifies that the patent is invalid or is not infringed by its product. (2) If patent holder sues within 45 days, the action automatically triggers a 30-MONTH STAY on FDA action (3) If patent holder does not sue within 45 days, FDA may approve ANDA, generic applicant is entitled to 180-DAY EXCLUSIVITY (4) When 30-MONTH STAY expires (5) FDA may approve ANDA. first generic applicant is entitled to 180-DAY EXCLUSIVITY (6) When 30-MONTH STAY has not expired (6A) If patent expires, FDA may approve ANDA, one or more generics may enter, no applicant is entitled to 180-DAY EXCLUSIVITY (6B) If court rules in favor of brand-name Co., FDA may not approve ANDA until patent expires, no generic may enter until patent expires, no applicant is entitled to 180-DAY EXCLUSIVITY (6C) If court rules in favor of generic Co., FDA may approve ANDA. First generic applicant is entitled to 180-DAY EXCLUSIVITY |
| UPDATE | 09.02 |
| COMPANY | This data is not available for free |
| LITERATURE REF. | This data is not available for free |
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