Generic competition · all medicines · read 12 November 2026
Is there a generic of Sodium Chloride, and who makes it?
Sodium Chloride appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 9 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 between 2.2 and 42.3 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.
- Sodium Chloride appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 9 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 between 2.2 and 42.3 years after the first brand approval.
- 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.
Solution, Injection
Four or more generic makers listed
Brand listed as marketed: Bacteriostatic Sodium Chloride 0.9% In Plastic Container, Sodium Chloride 0.9% and Sodium Chloride 0.9% In Plastic Container. 6 generic makers with 16 generic products listed as marketed; the first generic approval is dated 10 January 1985.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fresenius Kabi Usa Llc | 10 January 1985 | 6 |
| Taro Pharmaceuticals Usa Inc | 11 August 2006 | 2 |
| Hikma Pharmaceuticals Usa Inc | 24 September 2013 | 2 |
| Spectra Medical Devices Inc | 21 July 2017 | 2 |
| Nephron Pharmaceuticals Corporation | 23 April 2020 | 2 |
| Nexus Pharmaceuticals Llc | 23 August 2023 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Injection
Four or more generic makers listed
Brand listed as marketed: Sodium Chloride 0.45% In Plastic Container, Sodium Chloride 0.9%, Sodium Chloride 0.9% In Plastic Container and Sodium Chloride 3% In Plastic Container. 4 generic makers with 8 generic products listed as marketed; the first generic approval is dated 27 October 2004.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Gvs Tm Inc | 27 October 2004 | 1 |
| Fresenius Medical Care North America | 12 April 2007 | 1 |
| Laboratorios Grifols Sa | 25 May 2017 | 1 |
| Fresenius Kabi Usa Llc | 19 September 2017 | 5 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Irrigation
One to three generic makers listed
Brand listed as marketed: Sodium Chloride 0.9% In Plastic Container. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 24 June 2024.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fresenius Kabi Usa Llc | 24 June 2024 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Intravenous
One to three generic makers listed
Brand listed as marketed: Sodium Chloride 14.6% and Sodium Chloride 23.4%. 1 generic maker with 3 generic products listed as marketed; the first generic approval is dated 28 April 2021.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fresenius Kabi Usa Llc | 28 April 2021 | 3 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Aerosol, Metered, Inhalation
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution For Slush, Irrigation
Brand listed, no generic listed as marketed
Brand listed as marketed: Sodium Chloride 0.9% In Sterile Plastic Container. No generic is listed as marketed.
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.