FDA Status on Apotex's Ruxolitinib ANDA
Apotex filed an ANDA for a ruxolitinib phosphate topical suspension (1 mg/mL), the first for this formulation used to treat vitiligo. The FDA has not received the filing as of the latest public records, meaning no substantive responses—like tentative approval, final approval, or Paragraph IV notices—have been issued. Apotex triggered a 30-month stay under Hatch-Waxman by challenging Incyte's patents, delaying potential launch until at least December 2026.[1][2]
What Patents Is Apotex Challenging?
Apotex targets U.S. Patents 10,898,466 (expires Dec 23, 2026), 11,154,507 (Dec 23, 2026), 11,351,154 (Dec 23, 2026), 11,446,277 (expires later), and others listed in the Orange Book for Opzelura (ruxolitinib cream). Their Paragraph IV certification asserts these are invalid, unenforceable, or not infringed. Incyte received Apotex's notice on December 21, 2023, starting the stay clock.[1][2]
Timeline for FDA Action and Launch
No FDA acknowledgment or review milestones appear in the FDA's Paragraph IV Patent Litigation database or Orange Book updates. Earliest generic entry faces the 30-month stay ending June 2026, unless litigation resolves earlier. Incyte has until June 20, 2024, to sue Apotex, which could extend delays.[1][3]
Other Ruxolitinib ANDAs in the Pipeline
Apotex leads as the first filer for this topical form, eligible for 180-day exclusivity if approved. No other ANDAs for ruxolitinib topical suspension are public. Separate ANDAs exist for oral ruxolitinib (Jakafi), but topical filings remain limited due to Opzelura's 2022 approval and patent protections.[2][4]
Check Latest FDA Updates Yourself
Search the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) and Paragraph IV Patent Litigation database for real-time status. DrugPatentWatch tracks challenges: Ruxolitinib patent details.[2][5]
[1]: FDA Paragraph IV Patent Litigation Database, Incyte vs. Apotex (Ruxolitinib topical), filed Dec 2023.
[2]: DrugPatentWatch.com, Opzelura (ruxolitinib) ANDA litigation summary.
[3]: Hatch-Waxman Act, 21 U.S.C. § 355(j)(5)(B)(iii).
[4]: FDA Orange Book, Cumulative Supplement (latest).
[5]: DrugPatentWatch.com, Ruxolitinib patents and expirations.