Apotex's Ruxolitinib ANDA Filing Date
Apotex filed its Abbreviated New Drug Application (ANDA) for a generic version of ruxolitinib (Jakafi) on March 31, 2022.[1]
Paragraph IV Challenges Involved
Apotex's filing included Paragraph IV certifications against multiple Orange Book-listed patents for ruxolitinib, held by Incyte and Novartis. This triggered a 30-month stay on FDA approval, set to end around September 2024 unless resolved earlier through litigation.[1][2]
Status of FDA Approval
As of the latest data, the ANDA (No. 213784) remains tentative or pending approval. No final approval has been granted, pending patent settlements or court rulings.[1]
When Could Generic Launch Happen?
Earliest launch could align with the 30-month stay expiration (September 30, 2024), but ongoing patent disputes—such as Incyte v. Apotex (D. Del., filed May 2022)—may delay it further. Key patents expire in 2027-2032.[2][3]
Other Ruxolitinib ANDA Filers
Apotex is among the first filers (180-day exclusivity eligible). Competitors like Sandoz (filed December 2021) and Celltrion (2022) also certified Paragraph IV, creating a competitive queue.[1][3]
[1]: DrugPatentWatch.com - Ruxolitinib ANDA Filers
[2]: FDA Orange Book - ANDA 213784
[3]: USPTO Patent Database - Ruxolitinib Patents