When did apotex begin the ruxolitinib us filing process?

When did Apotex begin the ruxolitinib US filing process?

Apotex filed its Abbreviated New Drug Application (ANDA) for ruxolitinib tablets with the FDA in 2019.

What does an ANDA mean for ruxolitinib?

An ANDA lets a generic manufacturer submit data showing that its version matches the reference drug in quality, strength, purity, and route of administration. For ruxolitinib, Apotex used the brand-name reference listed drug Jakafi.

When does the Jakafi patent expire?

The main compound patent for ruxolitinib expired in 2026. The FDA listed no Paragraph IV certifications in Apotex's 2019 filing, meaning Apotex did not initially challenge the patents covering the drug.

How does Apotex's filing compete with other generics?

Several other companies filed later ANDAs for ruxolitinib. Later arrivals include Sun Pharma, Dr. Reddy's, and Zydus Lifesciences. Later filers can gain 180-day exclusivity if they prevail in patent litigation, but Apotex's early 2019 filing gives it seniority among competitors.

Can biosimilars enter before patent expiry?

Ruxolitinib is a small-molecule drug, not a biologic. Therefore biosimilars do not apply.