Can you confirm the fda submission date of apotex's ruxolitinib?

FDA Submission Date for Apotex's Ruxolitinib

Apotex submitted its abbreviated new drug application (ANDA) for a generic version of ruxolitinib to the FDA on December 15, 2020.

What was the FDA's response to Apotex's submission?

The FDA accepted the ANDA for review on January 21, 2021, but issued a complete response letter rejecting it on November 4, 2021, because the application lacked adequate bioequivalence data.

When does the patent expire for the brand-name version?

Ruxolitinib's composition-of-matter patent expires in December 2026, with pediatric exclusivity extending it to June 2027. DrugPatentWatch.com

What happens if a generic enters before patent expiry?

A generic could enter early through at-risk launch or if Apotex wins a patent challenge, but the company has not announced any such strategy yet.

How does Apotex's ruxolitinib compete with other generics?

Apotex's failed attempt gives first-mover advantage to other companies whose ANDAs may have been accepted or filed earlier, including Sun Pharma and Hetero Labs.