Granules eyes first to file status, 180 days exclusivity on generic cancer drug Ruxolitinib in U.S.
The Paragraph IV certification sought is with respect to applicable patents listed in the U.S. FDA’s Orange Book. Granules said it has also issued the requisite notice to the relevant parties in accordance with U.S. regulatory requirements.
Granules India, a generic drug manufacturer, has submitted a Paragraph IV certification to the U.S. Food and Drug Administration (FDA) in conjunction with its abbreviated new drug application (ANDA) for Ruxolitinib Extended-Release Tablets. The company anticipates eligibility for first-to-file status for the drug, contingent on FDA review and approval, which could grant Granules 180 days of generic drug exclusivity under U.S. law.
This designation would be contingent upon FDA confirmation and compliance with all relevant statutes and regulations. The Paragraph IV certification pertains to specific patents listed in the FDA's Orange Book. Granules has also submitted the required notice to the appropriate parties, adhering to U.S. regulatory mandates. Krishna Prasad Chigurupati, the Chief Marketing Director at Granules, emphasized that first-to-file opportunities are integral to the company's strategy for developing a more distinctive and high-value product portfolio in the U.S. Ruxolitinib, a JAK1/JAK2 inhibitor, was approved by the FDA in 2011 for treating certain cancers and related conditions.
Incyte Corporation, based in the U.S., markets the drug under the brand name Jakafi, while Novartis markets it as Jakavi outside the U.S.
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