Granules India files patent certification for ruxolitinib extended-release tablets
Granules India says it has submitted a Paragraph IV patent certification for its ruxolitinib extended-release tablet application in the US. The company believes it may qualify for first-to-file status, subject to FDA determination.
Granules India says it has submitted a Paragraph IV patent certification for its US application for ruxolitinib extended-release tablets and notified the relevant parties.
It believes it may qualify for first-to-file status, potentially allowing 180 days of generic exclusivity if the FDA confirms eligibility and other requirements are met. Neither product approval nor exclusivity is confirmed.
Disclosure: Granules has not disclosed the application’s strengths, a commercial launch date, expected revenue or an FDA determination confirming first-to-file status.
