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OmniRx › Tools › Generic competition check › Busulfan

Generic competition · all medicines · read 12 November 2026

Is there a generic of Busulfan, and who makes it?

Busulfan appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 7 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 16.9 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.
Busulfan2 dosage-form groups in the Orange Book
7generic makers listed
  1. Busulfan appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 7 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 16.9 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.

Injectable, Injection

Four or more generic makers listed

Brand listed as marketed: Busulfex. 7 generic makers with 7 generic products listed as marketed; the first generic approval is dated 22 December 2015.

1995200020052010201520202025203007brand 1999Pharmascience Inc, first approval 24 March 2017Amneal Eu Ltd, first approval 18 December 2017Hospira Inc, first approval 31 July 2018Accord Healthcare Inc Usa, first approval 22 February 2019Adaptis Pharma Private Ltd, first approval 18 April 2019Meitheal Pharmaceuticals Inc, first approval 23 October 2020Prinston Pharmaceutical Inc, first approval 11 September 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Pharmascience Inc24 March 20171
Amneal Eu Ltd18 December 20171
Hospira Inc31 July 20181
Accord Healthcare Inc Usa22 February 20191
Adaptis Pharma Private Ltd18 April 20191
Meitheal Pharmaceuticals Inc23 October 20201
Prinston Pharmaceutical Inc11 September 20241

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Tablet, Oral

Brand listed, no generic listed as marketed

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

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

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.