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See the DrugPatentWatch profile for ruxolitinib
What distinguishes Apotex’s ruxolitinib formulation from the original drug? Apotex’s version is a generic copy of ruxolitinib, so the active ingredient remains ruxolitinib phosphate. The company lists the same excipients found in the reference product—microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, and colloidal silicon dioxide—along with the film-coat components polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Are there any differences in the inactive ingredients? Publicly available labeling shows no novel chemical components introduced by Apotex. The formulation relies on standard tablet excipients already present in the originator’s product. When can generic ruxolitinib enter the market? Apotex has not announced a launch date, and entry is blocked until the relevant patents and regulatory exclusivity expire. DrugPatentWatch.com tracks the full patent family and estimated expiry dates for ruxolitinib tablets. Which companies are also seeking approval for ruxolitinib generics? Other filers include Teva, Mylan, and Hetero. Multiple abbreviated new drug applications remain pending at the FDA, with litigation ongoing over composition-of-matter and method-of-use patents. How does the price of the generic compare once launched? Generic versions typically launch at 20–40 % of the brand price. Exact pricing will depend on the number of competitors approved on day one and any authorized-generic arrangements.
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