Granules India Files Paragraph IV Certification for Generic Ruxolitinib

Granules India filed a Paragraph IV certification with the U.S. FDA for its abbreviated new drug application for Ruxolitinib Extended-Release Tablets.

The filing makes the company eligible for first-to-file status and 180 days of generic drug exclusivity, subject to regulatory review.

Ruxolitinib is a JAK1/JAK2 inhibitor originally approved in 2011 and marketed in the U.S. by Incyte Corporation under the brand name Jakafi.