No, Apotex has not publicly disclosed a specific ANDA filing date for ruxolitinib to the FDA.
What is Apotex's status on ruxolitinib generics?
Apotex is developing a generic version of ruxolitinib (Jakafi/Incyte), but no Paragraph IV ANDA filing date appears in FDA's Orange Book or public records. Apotex lists ruxolitinib on its pipeline for topical cream and oral formulations, targeting Paragraph IV challenges, yet lacks confirmed FDA submission details.[1]
When did other companies file ruxolitinib ANDAs?
Incyte's Jakafi faces multiple ANDAs:
- Sandoz filed first in March 2023 (180-day exclusivity holder).
- Lupin (May 2023), Dr. Reddy's (June 2023), and others followed.
Apotex is not listed among the 10+ challengers in FDA records as of late 2024.[2]
What blocks generic ruxolitinib entry?
Ruxolitinib patents expire 2027-2032, with pediatric exclusivity to 2033 for oral tablets. Litigation from Incyte delays approvals; tentative approvals exist for some ANDAs, but none for Apotex.[1][3]
Where to check for updates?
FDA's Orange Book lists approved ANDAs/paras; search "ruxolitinib" for filings. DrugPatentWatch tracks challenges—no Apotex entry.[1] Apotex investor updates occasionally mention pipeline progress without dates.
[1]: DrugPatentWatch.com/ruxolitinib
[2]: FDA Orange Book
[3]: FDA Paragraph IV Database