When was apotex's ruxolitinib approved?

When was apotex's ruxolitinib approved?

Health Canada approved Apotex's generic ruxolitinib tablets on 18 September 2024 for the treatment of myelofibrosis and polycythemia vera. The product is supplied as 5 mg, 10 mg, 15 mg, and 20 mg film-coated tablets.

What dosage strengths did Apotex receive approval for?

Apotex's generic comes in the same strengths as the reference product: 5 mg, 10 mg, 15 mg, and 20 mg. All four strengths were cleared together under one approval letter.

How does Apotex's approval affect the Canadian market for ruxolitinib?

With Apotex's entry, Canadian patients and provincial formularies now have an additional generic option alongside any other authorized generics. This increases price competition and can lower reimbursement costs for myelofibrosis and polycythemia vera therapy.

When does the Canadian patent for ruxolitinib expire?

The key Canadian patent covering ruxolitinib (CA 2,619,389) is listed to expire on 10 August 2026. Generic companies such as Apotex must still respect any remaining data exclusivity periods or court-ordered injunctions that could delay full launch.

Can Apotex launch immediately after the 18 September 2024 approval?

Apotex may begin selling once any remaining regulatory or patent barriers are cleared. Launch timing depends on final patent litigation outcomes and any Health Canada-imposed post-approval conditions.

Who makes the reference product in Canada?

Incyte holds the Canadian marketing authorization for the brand-name version, Jakavi. Novartis Canada markets and distributes the product under license from Incyte.

How does Health Canada's approval compare with the FDA timeline for generic ruxolitinib?

The FDA has not yet approved any generic ruxolitinib in the United States. Apotex's Canadian approval therefore precedes any U.S. generic launch by an unknown period, reflecting differences in patent challenge strategies and regulatory review times between the two jurisdictions.