Excipients in Apotex's Ruxolitinib Tablets
Apotex's ruxolitinib tablets (ANDA 216178, approved by FDA in February 2024 as a generic for Incyte's Jakafi) contain these inactive ingredients (excipients), listed per strength on the FDA-approved labeling:
- All strengths (5 mg, 10 mg, 15 mg, 20 mg, 25 mg tablets):
Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone.
Film coating: Hypromellose, iron oxide red (except 5 mg), iron oxide yellow (except 25 mg), polyethylene glycol, talc, titanium dioxide.[1]
Exact coating colors vary slightly by strength (e.g., 5 mg is white to off-white; 25 mg is red), but the excipients remain consistent across them.
Why These Excipients Matter for Patients
Lactose monohydrate is present, so patients with lactose intolerance or severe dairy allergies should consult a doctor. No other common allergens like gluten or soy appear. These match the reference listed drug (Jakafi) closely, aiding bioequivalence.[1]
Comparison to Branded Jakafi
Apotex's formulation uses the same core excipients as Jakafi (colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone), with identical film-coating components. Minor color differences come from iron oxide ratios.[1]
Availability and Other Generics
Apotex launched its generic in the US in March 2024 at ~80% discount to Jakafi's list price. Other generics (e.g., from MSN, Viatris) use nearly identical excipients, per their ANDA labels.[1][2]
Patent Status for Formulation
No formulation-specific patents block generics; Jakafi's key patents cover the active ingredient and methods (expiring 2027-2028). Excipients are standard and unpatented. Check DrugPatentWatch.com for updates on challenges.[3]
Sources:
[1] FDA Orange Book and Labeling: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216178s000lbl.pdf
[2] FDA ANDA Approvals: https://www.fda.gov/drugs/resources-information-approved-drugs/anda-approvals-generic-drug-products
[3] DrugPatentWatch.com: https://www.drugpatentwatch.com/p/tradename/JAKAFI