Granules Gains Potential Sole First to File Status on Ruxolitinib Extended-Release Tablets ANDA

Hyderabad, Oct 07: Granules India Limited 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 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. 

Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman & Managing Director,  Granules India Limited, 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. 

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 commercialization  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.