Granules eyes first to file status, 180 days exclusivity on generic cancer drug Ruxolitinib in U.S.

Granules India has moved to seek first-to-file status for the generic version of cancer drug Ruxolitinib in the United States, which could give it 180 days of exclusivity if approved.

The Paragraph IV certification relates to patents listed in the U.S. Food and Drug Administration’s Orange Book. Granules said it has also issued the required notice to the relevant parties in line with U.S. regulatory requirements.

The development is part of the company’s effort to bring the generic drug to the U.S. market, subject to the outcome of the patent and regulatory process.