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OmniRx › Tools › Generic competition check › Irinotecan Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Irinotecan Hydrochloride, and who makes it?

Irinotecan Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 14 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 11.7 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.
Irinotecan Hydrochloride2 dosage-form groups in the Orange Book
14generic makers listed
  1. Irinotecan Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 14 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 11.7 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.

Injectable, Injection

Four or more generic makers listed

Brand listed as marketed: Camptosar. 14 generic makers with 33 generic products listed as marketed; the first generic approval is dated 20 February 2008.

19952000200520102015202020252030014brand 1996Actavis Totowa Llc, first approval 27 February 2008Fresenius Kabi Usa Llc, first approval 27 February 2008Hospira Inc, first approval 27 February 2008Accord Healthcare Inc, first approval 21 November 2008Teva Pharmaceuticals Usa, first approval 26 November 2008Hikma Pharmaceuticals Usa Inc, first approval 24 December 2008Epic Pharma Llc, first approval 16 September 2009Hikma Farmaceutica (Portugal) Sa, first approval 20 December 2010Pharmobedient Consulting Llc, first approval 13 May 2011Qilu Pharmaceutical Hainan Co Ltd, first approval 3 May 2016Intas Pharmaceuticals Usa, first approval 31 August 2017Adaptis Pharma Private Ltd, first approval 28 December 2018Gland Pharma Ltd, first approval 18 November 2019Eugia Pharma Specialities Ltd, first approval 2 November 2020data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Actavis Totowa Llc27 February 20083
Fresenius Kabi Usa Llc27 February 20082
Hospira Inc27 February 20083
Accord Healthcare Inc21 November 20082
Teva Pharmaceuticals Usa26 November 20081
Hikma Pharmaceuticals Usa Inc24 December 20082
Epic Pharma Llc16 September 20092
Hikma Farmaceutica (Portugal) Sa20 December 20102
Pharmobedient Consulting Llc13 May 20112
Qilu Pharmaceutical Hainan Co Ltd3 May 20163
Intas Pharmaceuticals Usa31 August 20172
Adaptis Pharma Private Ltd28 December 20183

2 more makers are listed in the data.

Patents and exclusivities still listed

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

Injectable, Liposomal, Intravenous

Brand listed, no generic listed as marketed

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

20152020202520302035204001brand 2015data datePatent 8329213 listed to expire 6 January 2027Patent 8147867 listed to expire 29 August 2028Patent 9717724 listed to expire 12 June 2033Patent 9492442 listed to expire 12 June 2033Patent 9364473 listed to expire 12 June 2033Patent 12364691 listed to expire 12 June 2033Patent 11369597 listed to expire 12 June 2033Patent 9339497 listed to expire 12 June 2033Patent 9452162 listed to expire 12 June 2033Patent 10980795 listed to expire 12 June 2033Patent 11344552 listed to expire 19 August 2036Patent 12059497 listed to expire 15 October 2036Patent 10456360 listed to expire 15 October 2036Patent 10993914 listed to expire 15 October 2036Exclusivity I-932 to 13 February 2027Exclusivity ODE-463 to 13 February 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 13 February 2027Exclusivity I-932 Onivyde
  • 13 February 2031Exclusivity ODE-463 Onivyde
  • 6 January 2027Patent 8329213 drug substance
  • 29 August 2028Patent 8147867 drug substance
  • 12 June 2033Patent 9717724
  • 12 June 2033Patent 9492442
  • 12 June 2033Patent 9364473
  • 12 June 2033Patent 12364691
  • 12 June 2033Patent 11369597
  • 12 June 2033Patent 9339497

6 more patents are listed.

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.