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OmniRx › Tools › Generic competition check › Palonosetron Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Palonosetron Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 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 12.2 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.
Palonosetron Hydrochloride3 dosage-form groups in the Orange Book
12generic makers listed
  1. Palonosetron Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 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 12.2 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, Intravenous

Four or more generic makers listed

Every brand product here is listed as discontinued. 12 generic makers with 15 generic products listed as marketed; the first generic approval is dated 13 October 2015.

2000200520102015202020252030012brand 2003Sandoz Inc, first approval 13 October 2015Dr Reddys Laboratories Ltd, first approval 21 April 2016Teva Pharmaceuticals Usa, first approval 23 March 2018Chartwell Rx Sciences Llc, first approval 19 September 2018Fresenius Kabi Usa Llc, first approval 19 September 2018Hospira Inc, first approval 19 September 2018Mylan Institutional Llc, first approval 19 September 2018Qilu Pharmaceutical Hainan Co Ltd, first approval 19 September 2018Sagent Pharmaceuticals Inc, first approval 19 September 2018Eugia Pharma Specialities Ltd, first approval 6 November 2018Avet Lifesciences Ltd, first approval 29 June 2021Meitheal Pharmaceuticals Inc, first approval 14 August 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sandoz Inc13 October 20151
Dr Reddys Laboratories Ltd21 April 20161
Teva Pharmaceuticals Usa23 March 20181
Chartwell Rx Sciences Llc19 September 20181
Fresenius Kabi Usa Llc19 September 20182
Hospira Inc19 September 20181
Mylan Institutional Llc19 September 20181
Qilu Pharmaceutical Hainan Co Ltd19 September 20181
Sagent Pharmaceuticals Inc19 September 20182
Eugia Pharma Specialities Ltd6 November 20181
Avet Lifesciences Ltd29 June 20212
Meitheal Pharmaceuticals Inc14 August 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: Posfrea. No generic is listed as marketed.

201520202025203001brand 2016data 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.

Capsule, Oral

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

20052010201520202025203001brand 2008data 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.