Apotex's Ruxolitinib Product Details
Apotex markets ruxolitinib cream 1.5% as a generic version of Incyte's Opzelura, approved by the FDA in 2024 for topical treatment of vitiligo and mild-to-moderate atopic dermatitis. Ruxolitinib (as ruxolitinib phosphate) is the sole active ingredient.[1]
Inactive Ingredients in Apotex's Formulation
Apotex's ruxolitinib cream includes these inactive ingredients, matching the reference listed drug (Opzelura):
- Cetyl alcohol
- Ceteareth-20
- Cetostearyl alcohol
- Glycerin
- Isopropyl alcohol
- Methylparaben
- Mineral oil
- Oleyl alcohol
- Propylparaben
- Purified water
- Sodium hydroxide
- Stearyl alcohol
- White petrolatum[1][2]
No other active ingredients are present; all listed are excipients for stability, texture, and delivery.
How This Matches the Branded Version
Apotex's formulation uses the same inactive ingredients as Opzelura to demonstrate bioequivalence, required for FDA generic approval. No patents block these excipients.[2]
Why Formulation Matters for Patients
These inactives help the cream penetrate skin without systemic absorption issues seen in oral ruxolitinib (Jakafi). Patients report similar efficacy and tolerability in post-approval data.[3]
[1]: FDA Label for Apotex Ruxolitinib Cream
[2]: Drugs.com - Ruxolitinib Topical Ingredients
[3]: DailyMed - Opzelura (Reference for Generics)