Can you confirm apotex's ruxolitinib submission date in us?

What date did Apotex submit its ruxolitinib ANDA?

Apotex submitted its Abbreviated New Drug Application (ANDA) for ruxolitinib on May 29, 2019.

Does Apotex hold a first-to-file or Paragraph IV certification status?

Apotex did not receive first-to-file status on this ANDA. Multiple companies filed earlier or simultaneously, including Incyte’s reference product timing and Paragraph IV challenges from other generics.

What is the patent landscape surrounding Apotex’s ruxolitinib filing?

The core patents protecting ruxolitinib expire in 2026–2027. Apotex’s 2019 submission means it challenged several of these patents through Paragraph IV certification, allowing it to seek early entry if litigation settles favorably.

When does ruxolitinib exclusivity expire?

Ruxolitinib’s regulatory data exclusivity ended in November 2020. Patent protection remains the limiting factor, still active through 2026 or 2027.

How does Apotex’s ruxolitinib submission compete with other generics?

Apotex sits among a crowded field. Other manufacturers such as Hetero, Sun Pharma, and Incyte’s own generic partner have filed ANDAs with similar timing or earlier. The earliest submissions will gain six-month exclusivity if they prevail in litigation.

Can biosimilars enter before patent expiry?

Ruxolitinib is a small-molecule drug, not a biologic, therefore biosimilars are unavailable.