Granules India Limited (GIL) 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 US Food and Drug Administration’s (FDA) Orange Book. The company has also provided the required notice to the relevant parties in accordance with applicable US 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 US law.
The ANDA remains subject to FDA review. The announcement should not be construed as FDA approval of the product or confirmation by the FDA of first-to-file status or exclusivity.
Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India, said, “First-to-file opportunities are an important part of our strategy to build a more differentiated and higher-value product portfolio in the U.S. This filing reflects our focus on identifying technically and commercially attractive opportunities where our development and manufacturing capabilities can create sustainable value. We look forward to progressing the product through the regulatory process.”
The company will provide further updates, as appropriate, in accordance with applicable disclosure requirements.