Granules India Files Paragraph IV for Ruxolitinib ER Tablets, Eyes Potential 180-Day US Exclusivity
Hyderabad: Granules India Limited has submitted a Paragraph IV certification for its Abbreviated New Drug Application (ANDA) for Ruxolitinib Extended-Release Tablets with respect to applicable patents listed in the US Food and Drug Administration's (USFDA) Orange Book.
The company said it 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, Granules India believes it is eligible for first-to-file status for Ruxolitinib Extended-Release Tablets.
If confirmed by the USFDA and subject to satisfaction of all applicable statutory and regulatory requirements, first-to-file status may provide eligibility for 180 days of generic drug exclusivity under US law.
However, the ANDA remains subject to USFDA review. Granules India clarified that the announcement does not constitute USFDA approval of the product or confirmation by the regulator of the company's first-to-file status or any 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."
Granules India said it will provide further updates, as appropriate, in accordance with applicable disclosure requirements.
The company noted that the development involves forward-looking statements relating to its ANDA, potential first-to-file status, possible eligibility for 180-day exclusivity, regulatory review and commercialization prospects. These are subject to risks and uncertainties, including USFDA actions, patent litigation, exclusivity determinations and competition.
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