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

Generic drugmaker Granules India has filed a Paragraph IV certification with the U.S. Food and Drug Administration (U.S. FDA) in connection with its abbreviated new drug application (ANDA) for Ruxolitinib Extended-Release Tablets.

Based on the timing and status of its ANDA and Paragraph IV certification, and subject to the U.S. FDA’s review and determination, Granules said it believes it is eligible for first-to-file status for Ruxolitinib Extended-Release Tablets.

If confirmed by the FDA and subject to all applicable statutory and regulatory requirements, first-to-file status could make Granules eligible for 180 days of generic drug exclusivity under U.S. law, the company said on Wednesday (September 7, 2026).

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.

“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,” Granules CMD Krishna Prasad Chigurupati said.

Ruxolitinib, a JAK1/JAK2 inhibitor, was approved by the U.S. FDA in 2011 and is used to treat certain cancers and related conditions. In the U.S., the drug is developed and marketed by Incyte Corporation under the brand name Jakafi. Jakafi and Jakafi XR are trademarks of Incyte.

In May, Nasdaq-listed Incyte announced that the U.S. FDA had approved Jakafi XR, the extended-release formulation of ruxolitinib.

The drug is marketed by Incyte in the U.S. and by Novartis outside the country under the brand name Jakavi.