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OmniRx › Tools › Generic competition check › Gemcitabine Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Gemcitabine Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 13 generic makers listed as marketed across them. 2 groups have 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 14.5 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.
Gemcitabine Hydrochloride3 dosage-form groups in the Orange Book
13generic makers listed
  1. Gemcitabine Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 13 generic makers listed as marketed across them.
  2. 2 groups have 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 14.5 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

Brand listed as marketed: Gemcitabine Hydrochloride. 13 generic makers with 35 generic products listed as marketed; the first generic approval is dated 15 November 2010.

19952000200520102015202020252030013brand 1996Hospira Inc, first approval 15 November 2010Fresenius Kabi Usa Llc, first approval 16 May 2011Dr Reddys Laboratories Ltd, first approval 25 July 2011Hospira Worldwide, Inc, first approval 25 July 2011Sun Pharmaceutical Industries Ltd, first approval 25 July 2011Teyro Labs Private Ltd, first approval 25 July 2011Jiangsu Hansoh Pharmaceutical Group Co Ltd, first approval 7 May 2013Gland Pharma Ltd, first approval 5 January 2016Mylan Laboratories Ltd, first approval 6 December 2017Sagent Pharmaceuticals Inc, first approval 20 July 2018Adaptis Pharma Private Ltd, first approval 22 February 2019Meitheal Pharmaceuticals Inc, first approval 11 December 2020Hikma Pharmaceuticals International Ltd, first approval 7 March 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hospira Inc15 November 20101
Fresenius Kabi Usa Llc16 May 20114
Dr Reddys Laboratories Ltd25 July 20113
Hospira Worldwide, Inc25 July 20112
Sun Pharmaceutical Industries Ltd25 July 20112
Teyro Labs Private Ltd25 July 20112
Jiangsu Hansoh Pharmaceutical Group Co Ltd7 May 20132
Gland Pharma Ltd5 January 20162
Mylan Laboratories Ltd6 December 20173
Sagent Pharmaceuticals Inc20 July 20183
Adaptis Pharma Private Ltd22 February 20195
Meitheal Pharmaceuticals Inc11 December 20203

1 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.

Solution, Intravenous

Brand listed, no generic listed as marketed

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

201520202025203001brand 2017data 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.

System, Intravesical

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2025data datePatent 12403086 listed to expire 28 June 2030Patent 12576253 listed to expire 17 December 2030Patent 8679094 listed to expire 15 April 2032Patent 10729823 listed to expire 19 August 2034Patent 12447241 listed to expire 19 August 2034Patent 12636300 listed to expire 7 November 2038Exclusivity NP to 9 September 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 9 September 2028Exclusivity NP Inlexzo
  • 28 June 2030Patent 12403086 drug product
  • 17 December 2030Patent 12576253 drug product
  • 15 April 2032Patent 8679094 drug product
  • 19 August 2034Patent 10729823 drug product
  • 19 August 2034Patent 12447241 drug product
  • 7 November 2038Patent 12636300

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.