Granules India has submitted a Paragraph IV certification in connection with its Abbreviated New Drug Application (ANDA) for Ruxolitinib Extended-Release Tablets with respect to applicable patents listed I with the ’s (FDA)
The -based company 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, 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.
Differentiated Product
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.
“First-to-file opportunities are an important part of our strategy to build a more differentiated and higher-value product portfolio in the US” Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India said in a release on Wednesday.
“We look forward to progressing the product through the regulatory process,” he added.
The company will provide further updates, as appropriate, in accordance with applicable disclosure requirements, the release added.