Granules India submits Paragraph IV certification for Ruxolitinib ER Tablets ANDA

Granules India announced that it has submitted a Paragraph IV certification in connection with its ANDA for Ruxolitinib Extended-Release Tablets with respect to applicable patents listed in the U.S. Food and Drug Administration's (FDA) Orange Book and has provided the required notice to the relevant parties in accordance with applicable U.S. regulatory requirements.

Based on the timing and status of its ANDA and Paragraph IV certification and subject to FDA review and determination, GIL believes that it is eligible for first-to-file status for Ruxolitinib Extended-Release Tablets. If confirmed by the FDA and all applicable statutory and regulatory requirements are satisfied, first-to-file status may provide eligibility for 180 days of generic drug exclusivity under U.S. law.

The ANDA also remains subject to FDA review, and this announcement should not be construed as FDA approval of the product or confirmation by the FDA of first-to-file status or exclusivity.