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OmniRx › Tools › Generic competition check › Cyclophosphamide

Generic competition · all medicines · read 12 November 2026

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

Cyclophosphamide appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 between 4.2 and 4.5 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.
Cyclophosphamide4 dosage-form groups in the Orange Book
15generic makers listed
  1. Cyclophosphamide appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 between 4.2 and 4.5 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

Every brand product here is listed as discontinued. 9 generic makers with 27 generic products listed as marketed; the first generic approval is dated 16 February 1982.

1980198519901995200020052010201520202025203009brand 1982Baxter Healthcare Corp, first approval 21 May 2008Jiangsu Hengrui Pharmaceuticals Co Ltd, first approval 31 October 2014Amneal Eu Ltd, first approval 25 May 2018Xgen Pharmaceuticals Djb Inc, first approval 18 October 2022Sagent Pharmaceuticals Inc, first approval 17 July 2023Sunny Pharmtech Inc, first approval 26 October 2023Hikma Pharmaceuticals Usa Inc, first approval 18 December 2023Epic Pharma Llc, first approval 19 December 2024Hainan Poly Pharm Co Ltd, first approval 26 December 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Baxter Healthcare Corp21 May 20083
Jiangsu Hengrui Pharmaceuticals Co Ltd31 October 20143
Amneal Eu Ltd25 May 20183
Xgen Pharmaceuticals Djb Inc18 October 20223
Sagent Pharmaceuticals Inc17 July 20233
Sunny Pharmtech Inc26 October 20233
Hikma Pharmaceuticals Usa Inc18 December 20233
Epic Pharma Llc19 December 20243
Hainan Poly Pharm Co Ltd26 December 20243

Patents and exclusivities still listed

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

Solution, Intravenous

One to three generic makers listed

Brand listed as marketed: Cyclophosphamide and Frindovyx. 1 generic maker with 2 generic products listed as marketed; the first generic approval is dated 29 October 2024.

2020202520302035204001brand 2020Nexus Pharmaceuticals Llc, first approval 29 October 2024data datePatent 9662342 listed to expire 26 June 2035Patent 10849916 listed to expire 13 July 2035Patent 11382923 listed to expire 1 December 2035Patent 10993952 listed to expire 15 February 2036Patent 12329767 listed to expire 15 February 2036
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Nexus Pharmaceuticals Llc29 October 20242

Patents and exclusivities still listed

  • 26 June 2035Patent 9662342 drug product
  • 13 July 2035Patent 10849916 drug product
  • 1 December 2035Patent 11382923 drug product
  • 15 February 2036Patent 10993952 drug product
  • 15 February 2036Patent 12329767 drug product

Capsule, Oral

Four or more generic makers listed

Brand listed as marketed: Cyclophosphamide. 5 generic makers with 10 generic products listed as marketed; the first generic approval is dated 19 March 2018.

2010201520202025203005brand 2013Pharmazone, first approval 7 May 2018Cipla Ltd, first approval 18 January 2019Alembic Pharmaceuticals Ltd, first approval 10 November 2022Zydus Lifesciences Ltd, first approval 13 December 2023Eirgen Pharma Ltd, first approval 3 December 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Pharmazone7 May 20182
Cipla Ltd18 January 20192
Alembic Pharmaceuticals Ltd10 November 20222
Zydus Lifesciences Ltd13 December 20232
Eirgen Pharma Ltd3 December 20242

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: Cytoxan. No generic is listed as marketed (2 generic products listed as discontinued).

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.