Apotex's ANDA Filing for Ruxolitinib
Apotex filed an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of ruxolitinib (Jakafi), targeting the 5 mg, 10 mg, 15 mg, and 20 mg strengths. This filing positions them as a Paragraph IV challenger to Incyte's patents.[1][2]
Ongoing Patent Litigation
Incyte and Novartis sued Apotex in December 2023 over U.S. Patent Nos. 11,711,442 and 11,866,154, which cover topical formulations of ruxolitinib for non-melanoma skin cancer. The case is pending in the U.S. District Court for the District of Delaware (Civil Action No. 1:23-cv-01590). No trial date is set, and Apotex has opposed Incyte's motion to dismiss its counterclaims.[3][4]
FDA Status and Approval Timeline
Apotex's ANDA remains under FDA review with no public approval or tentative approval announced. Paragraph IV status triggers a 30-month stay on FDA approval until at least June 2026, unless litigation resolves earlier. The FDA has not listed it as approved or denied.[1][5]
Patent Expiry and Market Entry Risks
Key Jakafi patents expire in 2028 (composition of matter), with pediatric exclusivity extending to February 2029. Secondary patents face challenges, including from Apotex. If Apotex prevails, entry could occur post-2026 stay; loss risks injunction until 2032 for some formulations.[2][6]
Competitors in Ruxolitinib Generics
Apotex trails Sandoz (first ANDA filer, approved August 2024 for oral Jakafi generics) and others like MSN, Dr. Reddy's, and Celltrion, which have tentative approvals or ongoing suits. Apotex's focus includes topical Opzelura, differentiating it slightly.[1][7]
Sources
[1]: DrugPatentWatch.com - Ruxolitinib Patent Status
[2]: FDA Orange Book - Jakafi ANDAs
[3]: PACER - Incyte v. Apotex (Del. 1:23-cv-01590)
[4]: CourtListener - Docket Entries
[5]: FDA ANDA Approvals Database
[6]: DrugPatentWatch.com - Jakafi Patents
[7]: FDA Press Release - Sandoz Approval (Aug 2024)