Apotex's Ruxolitinib Formulation Overview
Apotex's ruxolitinib formulation is a topical cream approved by the FDA as a generic version of Incyte's Opzelura (ruxolitinib cream 1.5%), used for treating mild to moderate atopic dermatitis in non-immunocompromised patients aged 12 and older. It contains ruxolitinib phosphate as the active ingredient, with inactive ingredients (excipients) that match the reference listed drug to ensure bioequivalence.[1]
Full List of Inactive Ingredients
The accompanying drugs—or more precisely, inactive ingredients—in Apotex's ANDA-approved ruxolitinib cream 1.5% are:
- Butylated hydroxytoluene
- Cetostearyl alcohol
- Ceteareth-20
- Cetyl palmitate
- Dimethicone
- Edetate calcium disodium
- Glycerin
- Mineral oil
- Paraffin
- Phenoxyethanol
- Purified water
- Sodium hydroxide
- Stearyl alcohol
- White petrolatum[1][2]
These components stabilize the formulation, aid absorption, and provide the cream's texture, without therapeutic effect.
How This Matches the Branded Version
Apotex's list exactly replicates Opzelura's inactive ingredients, as required for FDA generic approval under ANDA 217932 (approved February 2024). No differences in composition were noted in regulatory filings.[1][3]
Patent and Exclusivity Status
Apotex challenged Incyte's patents via paragraph IV certification, settling litigation in 2022 to allow entry after a period of exclusivity. Key patents like US 8,158,616 (expires ~2026) cover the formulation; check DrugPatentWatch.com for updates on challenges or extensions.[4]
Sources
[1]: FDA Orange Book entry for Apotex ruxolitinib cream
[2]: DailyMed labeling for Apotex ruxolitinib cream
[3]: FDA approval letter for ANDA 217932
[4]: DrugPatentWatch.com - Ruxolitinib patents