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OmniRx › Tools › Generic competition check › Temozolomide

Generic competition · all medicines · read 12 November 2026

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

Temozolomide appears in 2 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 10.6 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.
Temozolomide2 dosage-form groups in the Orange Book
10generic makers listed
  1. Temozolomide appears in 2 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 10.6 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.

Capsule, Oral

Four or more generic makers listed

Every brand product here is listed as discontinued. 10 generic makers with 58 generic products listed as marketed; the first generic approval is dated 1 March 2010.

19952000200520102015202020252030010brand 1999Sun Pharmaceutical Industries Ltd, first approval 12 February 2014Amneal Pharmaceuticals, first approval 8 May 2015Eirgen Pharma Ltd, first approval 10 February 2016Chartwell Life Molecules Llc, first approval 12 April 2016Rising Pharma Holdings Inc, first approval 27 April 2016Chemi Spa, first approval 23 November 2016Accord Healthcare Inc, first approval 27 February 2017Deva Holding As, first approval 26 April 2017Zydus Pharmaceuticals Usa Inc, first approval 31 July 2017Hetero Labs Ltd Unit V, first approval 23 August 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sun Pharmaceutical Industries Ltd12 February 20146
Amneal Pharmaceuticals8 May 20156
Eirgen Pharma Ltd10 February 20164
Chartwell Life Molecules Llc12 April 20166
Rising Pharma Holdings Inc27 April 20166
Chemi Spa23 November 20166
Accord Healthcare Inc27 February 20176
Deva Holding As26 April 20176
Zydus Pharmaceuticals Usa Inc31 July 20176
Hetero Labs Ltd Unit V23 August 20246

Patents and exclusivities still listed

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

Powder, Intravenous

Brand listed, no generic listed as marketed

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

20052010201520202025203001brand 2009data 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.