Granules India has submitted a Paragraph IV certification in connection with its Abbreviated New Drug Application (ANDA) for Ruxolitinib Extended-Release (ER) Tablets with respect to applicable patents listed in the US Food and Drug Administration’s (FDA) Orange Book and has 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, the company believes that it is eligible for first-to-file status for Ruxolitinib ER 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 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.

Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman and 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 US. 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. This communication contains forward-looking statements relating to, among other things, the company's ANDA, potential first-to-file status, possible eligibility for 180-day exclusivity, regulatory review, and commercialisation prospects. Such statements are subject to risks and uncertainties, including those relating to FDA actions, patent litigation, exclusivity determinations, competition, and other factors, and actual outcomes may differ materially from those expressed or implied herein.