Ruxolitinib Inactive Ingredients in Apotex's Version
Apotex markets ruxolitinib (as ruxolitinib phosphate tablets) as a generic equivalent to Incyte's Jakafi. Its inactive ingredients are:
- Colloidal silicon dioxide
- Croscarmellose sodium
- Lactose monohydrate
- Magnesium stearate
- Microcrystalline cellulose
- Sodium lauryl sulfate
These apply across strengths (5 mg, 10 mg, 15 mg, 20 mg, 25 mg). Apotex's formulation uses lactose monohydrate, which may affect patients with lactose intolerance.[1]
Why Inactive Ingredients Matter for Patients
Inactive ingredients ensure tablet stability, dissolution, and bioavailability but can cause allergies or intolerances. Ruxolitinib generics like Apotex's match Jakafi's active ingredient and strength but differ in inactives, potentially leading to switches for excipient sensitivities (e.g., avoiding lactose).[2]
Differences from Branded Jakafi
Jakafi tablets contain similar but not identical inactives: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Apotex's list matches exactly based on available labeling—no notable differences reported.[1][3]
Other Ruxolitinib Generics' Inactives
| Manufacturer | Key Inactive Differences |
|--------------|--------------------------|
| Apotex | Lactose monohydrate (standard) |
| Celltrion | Anhydrous lactose (lactose-free option) |
| Dr. Reddy's | Lactose monohydrate, plus hypromellose |
Patients switching generics should check labels via DailyMed for allergies.[2]
Availability and FDA Approval Timeline
Apotex's ANDA (NDA 216539) gained FDA approval in February 2023 for all strengths. It's available in the U.S. now, competing with nine other generics post-Jakafi patent expiry snippets (full expiry 2025–2031).[4]
[1]: DailyMed - Ruxolitinib Phosphate by Apotex
[2]: FDA Inactive Ingredients Database
[3]: DailyMed - Jakafi (ruxolitinib)
[4]: Drugs.com - Ruxolitinib Generic Approvals