Generic competition · all medicines · read 12 November 2026
Is there a generic of Lidocaine Hydrochloride, and who makes it?
Lidocaine Hydrochloride appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 26 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 0.9 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.
- Lidocaine Hydrochloride appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 26 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 0.9 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.
Injectable, Injection
Four or more generic makers listed
Brand listed as marketed: Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container, Lidocaine Hydrochloride 0.4% And Dextrose 5% In Plastic Container, Lidocaine Hydrochloride 0.8% And Dextrose 5% In Plastic Container and Lidocaine Hydrochloride Preservative Free. 15 generic makers with 46 generic products listed as marketed; the first generic approval is dated 2 February 1983.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| International Medication System | not dated | 2 |
| West-Ward Pharmaceuticals International Ltd | not dated | 2 |
| Hikma Pharmaceuticals Usa Inc | not dated | 2 |
| Hospira Inc | 17 May 1984 | 12 |
| Fresenius Kabi Usa Llc | 24 July 1985 | 3 |
| Eugia Pharma Specialities Ltd | 14 March 2013 | 4 |
| Spectra Medical Devices Inc | 18 April 2018 | 1 |
| B Braun Medical Inc | 3 August 2018 | 1 |
| Huons Co Ltd | 7 May 2020 | 2 |
| Aspiro Pharma Ltd | 8 November 2021 | 4 |
| Pharmobedient Consulting Llc | 5 May 2022 | 3 |
| Heritage Pharmaceuticals Inc Dba Avet Pharmaceuticals Inc | 9 June 2022 | 1 |
3 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, Topical
Four or more generic makers listed
Every brand product here is listed as discontinued. 8 generic makers with 8 generic products listed as marketed; the first generic approval is dated 18 November 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| International Medication System | not dated | 1 |
| Pharmobedient Consulting Llc | 18 November 1982 | 1 |
| Hikma Pharmaceuticals Usa Inc | 3 April 1985 | 1 |
| Lannett Co Inc | 27 February 2007 | 1 |
| Pai Holdings Llc Dba Pharmaceutical Associates Inc | 12 March 2014 | 1 |
| Novitium Pharma Llc | 23 March 2022 | 1 |
| Sun Pharma Canada Inc | 7 December 2023 | 1 |
| The J Molner Co Ou | 29 April 2024 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Oral
Four or more generic makers listed
Every brand product here is listed as discontinued. 7 generic makers with 7 generic products listed as marketed; the first generic approval is dated 2 February 1982.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Pharmobedient Consulting Llc | 18 November 1982 | 1 |
| Hikma Pharmaceuticals Usa Inc | 26 April 1985 | 1 |
| Chartwell Molecular Holdings Llc | 27 February 2007 | 1 |
| Rubicon Research Ltd | 28 March 2023 | 1 |
| Pai Holdings Llc Dba Pharmaceutical Associates Inc | 20 February 2024 | 1 |
| Aurobindo Pharma Ltd | 29 July 2025 | 1 |
| Quagen Pharmaceuticals Llc | 20 March 2026 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Jelly, Topical
One to three generic makers listed
Every brand product here is listed as discontinued. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 29 April 1993.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| International Medication System | not dated | 1 |
| Sentiss Ag | 12 February 2003 | 1 |
| Sagent Pharmaceuticals Inc | 28 April 2014 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Spinal
One to three generic makers listed
Every brand product here is listed as discontinued. 1 generic maker with 1 generic product listed as marketed.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hospira Inc | not dated | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Gel, Ophthalmic
Brand listed, no generic listed as marketed
Brand listed as marketed: Akten. 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.
System, Intradermal
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.
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.