Generic competition · all medicines · read 12 November 2026
Is there a generic of Metronidazole, and who makes it?
Metronidazole appears in 9 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 24 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 2.3 and 17.5 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.
- Metronidazole appears in 9 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 24 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 2.3 and 17.5 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.
Tablet, Oral
Four or more generic makers listed
Every brand product here is listed as discontinued. 11 generic makers with 23 generic products listed as marketed; the first generic approval is dated 6 November 1984.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Usa Inc | 6 November 1984 | 1 |
| Pliva Inc | 6 December 1984 | 1 |
| Watson Laboratories Inc | 20 December 1984 | 2 |
| Innogenix Llc | 16 July 1986 | 3 |
| Alembic Pharmaceuticals Ltd | 13 March 2009 | 4 |
| Unichem Laboratories Ltd | 22 January 2014 | 2 |
| Aurobindo Pharma Ltd | 29 May 2015 | 2 |
| Somerset Therapeutics Llc | 23 September 2015 | 2 |
| Novitium Pharma Llc | 25 May 2016 | 2 |
| Cadila Healthcare Ltd | 16 November 2016 | 2 |
| Cadila Pharmaceuticals Ltd | 12 December 2017 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Injection
One to three generic makers listed
Brand listed as marketed: Flagyl I.v. Rtu In Plastic Container and Metronidazole In Plastic Container. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 3 December 1984.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Inforlife Sa | 25 February 2019 | 1 |
| Gland Pharma Ltd | 3 August 2020 | 1 |
| Amneal Eu Ltd | 24 May 2023 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Gel, Topical
Four or more generic makers listed
Brand listed as marketed: Metrogel. 7 generic makers with 9 generic products listed as marketed; the first generic approval is dated 6 June 2006.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fougera Pharmaceuticals Inc | 6 June 2006 | 1 |
| Encube Ethicals Private Ltd | 13 July 2006 | 1 |
| Taro Pharmaceutical Industries Ltd | 18 July 2006 | 2 |
| Cosette Pharmaceuticals Nc Laboratories Llc | 19 January 2011 | 2 |
| Alembic Pharmaceuticals Ltd | 3 September 2021 | 1 |
| Aurobindo Pharma Ltd | 15 October 2024 | 1 |
| Zydus Lifesciences Ltd | 13 February 2026 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Gel, Vaginal
Four or more generic makers listed
Brand listed as marketed: Nuvessa and Vandazole. 7 generic makers with 7 generic products listed as marketed; the first generic approval is dated 31 October 2006.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Padagis Israel Pharmaceuticals Ltd | 2 July 2019 | 1 |
| Amvika Pharma Llc | 14 October 2021 | 1 |
| Glenmark Pharmaceuticals Ltd | 27 January 2022 | 1 |
| Encube Ethicals Private Ltd | 16 June 2023 | 1 |
| Cosette Pharmaceuticals Nc Laboratories Llc | 12 July 2023 | 1 |
| Sciegen Pharmaceuticals Inc | 31 December 2024 | 1 |
| Aurobindo Pharma Ltd | 25 September 2026 | 1 |
Patents and exclusivities still listed
- 2 February 2028Patent 8877792 drug product
- 19 February 2028Patent 7893097 drug product
- 27 June 2028Patent 8658678
- 28 June 2032Patent 9198858
- 28 June 2032Patent 8946276
- 28 June 2032Patent 10238634 drug product
- 28 June 2032Patent 10596155 drug product
Cream, Topical
Four or more generic makers listed
Brand listed as marketed: Metrocream and Noritate. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 28 May 2004.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fougera Pharmaceuticals Inc | 28 May 2004 | 1 |
| Cosette Pharmaceuticals Nc Laboratories Llc | 19 December 2007 | 1 |
| Zydus Lifesciences Ltd | 21 April 2023 | 1 |
| Aurobindo Pharma Ltd | 9 July 2025 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Capsule, Oral
One to three generic makers listed
Brand listed as marketed: Flagyl. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 13 November 2003.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Chartwell Rx Sciences Llc | 29 January 2004 | 1 |
| Alembic Pharmaceuticals Ltd | 23 June 2009 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Extended Release, Oral
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed (2 generic products listed as discontinued).
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Lotion, Topical
One to three generic makers listed
Brand listed as marketed: Metrolotion. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 24 May 2006.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fougera Pharmaceuticals Inc | 24 May 2006 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Suspension, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Likmez. No generic is listed as marketed.
Patents and exclusivities still listed
- 16 January 2039Patent 12257236 drug product
- 4 October 2039Patent 11541035 drug product
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.