Active Ingredient in Apotex's Ruxolitinib
Apotex's ruxolitinib is a generic version of Incyte/BMS's Jakafi (ruxolitinib phosphate), approved as 5 mg, 10 mg, 15 mg, and 20 mg film-coated tablets. The active ingredient is ruxolitinib phosphate, equivalent to 5 mg, 10 mg, 15 mg, or 20 mg of ruxolitinib free base per tablet.[1]
Inactive Ingredients (Excipients)
Apotex's formulation includes these inactive substances, consistent across strengths:
- Colloidal silicon dioxide
- Croscarmellose sodium
- Hypromellose
- Lactose monohydrate
- Magnesium stearate
- Microcrystalline cellulose
- Polyethylene glycol
- Sodium chloride
- Titanium dioxide
- Yellow iron oxide (in 15 mg and 20 mg tablets only)
These match the reference listed drug (Jakafi) formulation, as required for FDA generic approval via ANDA pathway.[1][2]
Why These Excipients Matter
Excipients aid tablet formation, dissolution, and stability but can cause issues for some patients. Lactose monohydrate, for instance, affects those with lactose intolerance. No unique additives distinguish Apotex's version from other generics like those from Celgene or Incyte's authorized versions.[1]
How It Compares to Jakafi
Apotex's inactive ingredients are identical to Jakafi's, ensuring bioequivalence (90% confidence interval for AUC and Cmax within 80-125%). No formulation differences reported in FDA labeling.[1][2]
Patent Status for Formulation
Ruxolitinib patents focus on the active molecule (e.g., US 7,598,257, expires 2027), not excipients. Generic formulations like Apotex's avoid patent issues by matching approved inactive lists. Check DrugPatentWatch.com for updates on Paragraph IV challenges or expirations.[3]
[1]: FDA Orange Book and labeling for Apotex's ruxolitinib phosphate tablets (NDC 60505-4120).
[2]: FDA-approved labeling for Jakafi (ruxolitinib) tablets.
[3]: DrugPatentWatch.com - Ruxolitinib Patents