Can you tell me when ruxolitinib andas including apotex were submitted?

When did Apotex submit its ANDA for ruxolitinib?

Apotex submitted an ANDA for ruxolitinib on May 22, 2018. This entry included a Paragraph IV certification against the patents protecting Incyte's original ruxolitinib phosphate tablets marketed as Jakafi.

How many ruxolitinib ANDAs has the FDA received so far?

The FDA has logged at least six ruxolitinib ANDA submissions from companies including Apotex, Sun Pharma, Hetero, and others. These filings span 2018 to 2021.

Why are companies challenging the ruxolitinib patents?

Companies pursue Paragraph IV certifications in their ANDAs to challenge Incyte's patents before they expire. The challenges typically target formulation, polymorph, and composition-of-matter patents that keep generic versions off the market.

What is the earliest possible launch date for ruxolitinib generics?

The earliest possible launch date for ruxolitinib generics is May 2026. This date follows from Incyte's pediatric exclusivity that extends protection through April 2026 on the key patents challenged by the Apotex filing.

When does the ruxolitinib patent expire?

Incyte's key patents covering ruxolitinib phosphate are set to expire in April 2026, with pediatric exclusivity pushing the final date to May 2026. [1]

Can biosimilars or generics of ruxolitinib enter before patent expiry?

No, current law requires generic ruxolinitis tablets to wait until the extended patents expire in May 2026. No at-risk launches have been reported from any of the submitted ANDAs.

Who makes the original ruxolitinib product?

Incyte Corporation manufactures the original ruxolitinib product under the brand name Jakafi.