Can you provide the specific date for apotex's ruxolitinib us filing?

When did Apotex file its ruxolitinib ANDA?

Apotex submitted its Abbreviated New Drug Application for ruxolitinib in the United States on 19 December 2022.

What is the current status of that filing?

The FDA accepted the application for review on 17 February 2023. No approval date has been announced.

Which patents is Apotex challenging?

Apotex’s filing targets patents listed in the Orange Book for Jakafi, specifically U.S. Patent Nos. 7,598,257; 8,420,629; 8,741,895; 9,079,910; and 9,216,984.

When do the key patents expire?

The last-listed patent expires on 7 December 2028. Apotex is seeking approval before that date through a Paragraph IV certification.

Has any litigation started?

Incyte filed a patent-infringement lawsuit against Apotex on 3 April 2023 in the U.S. District Court for the District of Delaware. The case remains ongoing.

Are other companies also targeting ruxolitinib?

Yes. Several additional generic manufacturers, including Teva, MSN, and Hetero, have filed their own ANDAs and are involved in separate litigation with Incyte.