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OmniRx › Tools › Generic competition check › Fluorouracil

Generic competition · all medicines · read 12 November 2026

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

Fluorouracil appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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 7.5 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.
Fluorouracil4 dosage-form groups in the Orange Book
10generic makers listed
  1. Fluorouracil appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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 7.5 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. 7 generic makers with 23 generic products listed as marketed; the first generic approval is dated 13 October 1982.

1995200020052010201520202025203007brand 2016Fresenius Kabi Usa Llc, first approval 30 September 1998Accord Healthcare Inc, first approval 26 April 2007Eugia Pharma Specialities Ltd, first approval 17 July 2012Sagent Pharmaceuticals Inc, first approval 17 February 2016Gland Pharma Ltd, first approval 27 October 2017Alembic Pharmaceuticals Ltd, first approval 3 March 2023Kindos Pharmaceuticals Co Ltd, first approval 24 September 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Fresenius Kabi Usa Llc30 September 19984
Accord Healthcare Inc26 April 20073
Eugia Pharma Specialities Ltd17 July 20124
Sagent Pharmaceuticals Inc17 February 20164
Gland Pharma Ltd27 October 20174
Alembic Pharmaceuticals Ltd3 March 20232
Kindos Pharmaceuticals Co Ltd24 September 20242

Patents and exclusivities still listed

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

Cream, Topical

Four or more generic makers listed

Brand listed as marketed: Carac, Efudex and Tolak. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 11 April 2008.

200020052010201520202025203004brand 2000Dr Reddys Laboratories Sa, first approval 11 April 2008Taro Pharmaceutical Industries Ltd, first approval 5 March 2010Accord Healthcare Inc, first approval 7 October 2021Encube Ethicals Private Ltd, first approval 12 February 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Dr Reddys Laboratories Sa11 April 20081
Taro Pharmaceutical Industries Ltd5 March 20101
Accord Healthcare Inc7 October 20211
Encube Ethicals Private Ltd12 February 20251

Patents and exclusivities still listed

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

Solution, Topical

One to three generic makers listed

Brand listed as marketed: Efudex. 2 generic makers with 3 generic products listed as marketed; the first generic approval is dated 5 November 2003.

200020052010201520202025203002Taro Pharmaceutical Industries Ltd, first approval 5 November 2003Encube Ethicals Private Ltd, first approval 2 November 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Taro Pharmaceutical Industries Ltd5 November 20032
Encube Ethicals Private Ltd2 November 20231

Patents and exclusivities still listed

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

Solution, Intravenous

Brand listed, no generic listed as marketed

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

20202025203001brand 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

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.