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OmniRx › Tools › Generic competition check › Bosutinib Monohydrate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Bosutinib Monohydrate, and who makes it?

Bosutinib Monohydrate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 12.7 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Bosutinib Monohydrate2 dosage-form groups in the Orange Book
2generic makers listed
  1. Bosutinib Monohydrate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 generic makers listed as marketed across them.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came 12.7 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Oral

One to three generic makers listed

Brand listed as marketed: Bosulif. 2 generic makers with 3 generic products listed as marketed; the first generic approval is dated 23 May 2025.

20102015202020252030203502brand 2012Alembic Pharmaceuticals Ltd, first approval 23 May 2025Msn Laboratories Private Ltd, first approval 12 June 2026data datePatent 7767678 listed to expire 23 November 2026Patent 7767678*PED listed to expire 23 May 2027Patent 11103497 listed to expire 28 February 2034Patent 11103497*PED listed to expire 28 August 2034Exclusivity PED to 26 March 2027Exclusivity ODE-444 to 26 September 2030Exclusivity PED to 26 March 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Alembic Pharmaceuticals Ltd23 May 20252
Msn Laboratories Private Ltd12 June 20261

Patents and exclusivities still listed

  • 26 March 2027Exclusivity PED Bosulif
  • 26 September 2030Exclusivity ODE-444 Bosulif
  • 26 March 2031Exclusivity PED Bosulif
  • 23 November 2026Patent 7767678 drug substance
  • 23 May 2027Patent 7767678*PED
  • 28 February 2034Patent 11103497
  • 28 August 2034Patent 11103497*PED

Capsule, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Bosulif. No generic is listed as marketed.

202020252030203501brand 2023data datePatent 7767678 listed to expire 23 November 2026Patent 7767678*PED listed to expire 23 May 2027Patent 11103497 listed to expire 28 February 2034Patent 11103497*PED listed to expire 28 August 2034Exclusivity PED to 26 March 2027Exclusivity ODE-444 to 26 September 2030Exclusivity PED to 26 March 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 26 March 2027Exclusivity PED Bosulif
  • 26 September 2030Exclusivity ODE-444 Bosulif
  • 26 March 2031Exclusivity PED Bosulif
  • 23 November 2026Patent 7767678 drug substance
  • 23 May 2027Patent 7767678*PED
  • 28 February 2034Patent 11103497
  • 28 August 2034Patent 11103497*PED

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.