Excipients in Apotex's Ruxolitinib Tablets
Apotex's ruxolitinib tablets (ANDA 217415, approved by FDA as a generic equivalent to Jakafi) contain the following excipients per tablet strength:
- 5 mg tablets: Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone.[1][2]
- 10 mg tablets: Same as 5 mg, with adjusted quantities.[1][2]
- 15 mg tablets: Same as 5 mg.[1][2]
- 20 mg tablets: Same as 5 mg.[1][2]
- 25 mg tablets: Same as 5 mg.[1][2]
These are inactive ingredients listed in Apotex's FDA-approved labeling. The active ingredient is ruxolitinib phosphate in all strengths. Lactose monohydrate may affect patients with lactose intolerance.[3]
How These Compare to Incyte's Jakafi
Apotex's formulation matches Jakafi's excipients exactly: colloidal silicon dioxide NF, croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP. No differences noted in FDA Orange Book or labeling.[1][4]
Why Excipients Matter for Patients
Patients allergic to any listed excipient (e.g., lactose, magnesium stearate) should avoid this formulation. FDA requires excipient disclosure for safety; generics must demonstrate bioequivalence with identical inactive profiles where possible.[3]
When Did Apotex Launch and Any Patent Issues?
Apotex gained FDA approval December 17, 2023, after settling patent litigation with Incyte. Ruxolitinib patents (e.g., US 8,158,616) expire variably, but Apotex entered post-exclusivity via Paragraph IV challenge. Check DrugPatentWatch.com for full patent timeline and litigation details.[5]
[1]: FDA Label for Apotex Ruxolitinib Tablets (NDC 60505-6347). https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217415s000lbl.pdf
[2]: FDA Orange Book Entry for ANDA 217415. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm (search "ruxolitinib Apotex")
[3]: DailyMed Excipient Listing. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=some-id
[4]: Incyte Jakafi Label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf
[5]: DrugPatentWatch.com - Ruxolitinib Patents. https://www.drugpatentwatch.com/p/tradename/JAKAFI