What ingredients accompany ruxolitinib in apotex's formulation?

What other ingredients are in Apotex's ruxolitinib tablets?

Apotex's ruxolitinib tablets contain the active ingredient ruxolitinib phosphate along with several inactive ingredients that help form the tablet, shape it, and enable proper disintegration and absorption in the body. The specific formulation includes microcrystalline cellulose, magnesium stearate, and hydroxypropyl cellulose as core excipients. The film coating consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red, and iron oxide yellow.

What does each ingredient do in the tablet?

Microcrystalline cellulose acts as a diluent and binder to keep the table solid and compact. Magnesium stearate serves as a lubricant so that the table presses correctly during manufacturing. Hydroxypropyl cellulose is another binder that also helps the table disintegrate properly. The film coating protects the table from moisture and gives it a colored appearance for easy identification. Polyvinyl alcohol and polyethylene glycol maintain coating integrity and smoothness. Talc and the iron oxides provide color and flow properties.

How does this formulation differ from the original innovator version?

The generic formulation by Apotex matches the active ingredient amount and delivery method of the original ruxolitinib from Incyte, but uses a different set of inactive ingredients. The original has a more complex coating system that includes croscarmellose sodium, colloidal silicon dioxide, and povidone as core fillers and binders. The generic avoids these and relies instead on magnesium stearate and hydroxypropyl cellulose.

How long does Apotex hold a patent or exclusivity on its formulation?

Apotex does not hold a patent on ruxolitinib or its formulation. Ruxolitinib is still under patent protection by Incyte through at