Evoke Pharma (EVOK) announced that a joint stipulation of dismissal has been filed in the GIMOTI patent infringement case in the United States District Court for the District of New Jersey. The filing of the stipulation arises from Teva Pharmaceuticals (TEVA) and Teva Pharmaceuticals USA’s conversion from a Paragraph IV certification to a Paragraph III certification. A paragraph III Abbreviated New Drug Application is not eligible for approval until the last expiration date of current and potential future orange book listed patents for the reference listed drug in conjunction with appropriate FDA review. In addition, no future ANDA filer will be eligible to receive 180-day generic exclusivity for an ANDA that references GIMOTI. This first-to-file regulatory pathway is typically highly sought after by generic firms.
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