Apotex's Ruxolitinib FDA Submission Date
Apotex submitted its abbreviated new drug application (ANDA) for a generic version of ruxolitinib (Jakafi) to the FDA on May 28, 2021.[1]
What Paragraph IV Certification Means Here
Apotex's filing included a Paragraph IV certification, challenging patents listed for Incyte's Jakafi in the FDA's Orange Book. This triggered a 30-month stay on FDA approval, delaying potential market entry until November 2023 unless resolved earlier through litigation.[1][2]
Status of Apotex's ANDA
As of latest data, Apotex's ANDA (No. 215146) remains tentative due to ongoing patent disputes. No final approval has been granted.[1]
Other Generic Challengers for Ruxolitinib
Apotex is one of several filers:
- Sandoz: Submitted March 31, 2021 (first-to-file status, eligible for 180-day exclusivity).
- Celltrion: Submitted November 30, 2021.
- MSN Labs: Submitted December 28, 2021.[1]
| Company | ANDA No. | Submission Date | Status |
|---------|----------|-----------------|--------|
| Sandoz | 213078 | Mar 31, 2021 | Tentative |
| Apotex | 215146 | May 28, 2021 | Tentative |
| Celltrion | 216093 | Nov 30, 2021 | Tentative |
| MSN Labs | 216457 | Dec 28, 2021 | Tentative |
Key Jakafi Patents and Expiry
Core patents expire in phases:
- Composition patent (US 7,598,257): February 2027.
- Method-of-use patents extend to 2031-2033.
Litigation with Apotex and others is active in Delaware federal court.[2]
[1]: DrugPatentWatch.com - Ruxolitinib ANDA Filers
[2]: FDA Orange Book - Jakafi Patent Listings