Regulatory
Granules India eyes potential 180-day US exclusivity for Ruxolitinib ER
Granules India believes it may qualify for first-to-file status for Ruxolitinib Extended-Release Tablets, subject to FDA review and determination
- By IPP Bureau
| October 08, 2026
Granules India Limited has moved to strengthen its US generics pipeline, filing a Paragraph IV certification for its Abbreviated New Drug Application (ANDA) covering Ruxolitinib Extended-Release Tablets.
The company said the filing relates to applicable patents listed in the US Food and Drug Administration’s (FDA) Orange Book and that it has issued the required notice to the relevant parties under US regulatory requirements.
Based on the timing and status of its ANDA and Paragraph IV certification, Granules India believes it may qualify for first-to-file status for Ruxolitinib Extended-Release Tablets, subject to FDA review and determination.
If the FDA confirms the status and all applicable statutory and regulatory requirements are met, the designation could make Granules eligible for 180 days of generic drug exclusivity in the US.
However, the company stressed that the ANDA remains under FDA review and that the filing does not amount to FDA approval or confirmation of first-to-file status or exclusivity.
If the FDA confirms the status and all applicable statutory and regulatory requirements are met, the designation could make Granules eligible for 180 days of generic drug exclusivity in the US.
However, the company stressed that the ANDA remains under FDA review and that the filing does not amount to FDA approval or confirmation of first-to-file status or exclusivity.
Commenting on the development, 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 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.”
