Generic competition · all medicines · read 12 November 2026
Is there a generic of Vancomycin Hydrochloride, and who makes it?
Vancomycin Hydrochloride appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 21 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 26 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.
- Vancomycin Hydrochloride appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 21 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 26 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
Generics listed, no brand listed
No brand application is listed. 13 generic makers with 49 generic products listed as marketed; the first generic approval is dated 15 March 1984.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fresenius Kabi Usa Llc | 17 March 1987 | 5 |
| Hospira Inc | 4 August 1988 | 9 |
| Eurofarma Inc | 30 June 2008 | 2 |
| Mylan Laboratories Ltd | 30 December 2008 | 4 |
| Sagent Pharmaceuticals Inc | 10 August 2012 | 2 |
| Hikma Pharmaceuticals Usa Inc | 28 December 2015 | 3 |
| Xellia Pharmaceuticals Aps | 28 December 2015 | 2 |
| Gland Pharma Ltd | 21 January 2016 | 4 |
| Eugia Pharma Specialities Ltd | 29 March 2016 | 4 |
| Hikma Farmaceutica Portugal Sa | 15 October 2018 | 3 |
| Hainan Poly Pharm Co Ltd | 12 June 2019 | 4 |
| Aspiro Pharma Ltd | 6 July 2022 | 2 |
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.
Powder, Intravenous
Four or more generic makers listed
Brand listed as marketed: Vancomycin Hydrochloride. 5 generic makers with 11 generic products listed as marketed; the first generic approval is dated 6 January 2016.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Samson Medical Technologies Llc | 6 January 2016 | 1 |
| Hikma Pharmaceuticals Usa Inc | 29 June 2023 | 2 |
| Eugia Pharma Specialities Ltd | 4 August 2023 | 2 |
| Gland Pharma Ltd | 21 March 2025 | 3 |
| Steriscience Pte Ltd | 2 October 2025 | 3 |
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: Vancocin Hydrochloride. 3 generic makers with 6 generic products listed as marketed; the first generic approval is dated 9 April 2012.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Pai Holdings Llc Dba Pharmaceutical Associates Inc And Dba Pai Pharma | 9 April 2012 | 2 |
| Strides Pharma Global Pte Ltd | 9 April 2012 | 2 |
| Orient Pharma Co Ltd | 29 April 2019 | 2 |
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: Tyzavan and Vancomycin Hydrochloride In Plastic Container. No generic is listed as marketed.
Patents and exclusivities still listed
- 6 November 2035Patent 11517609
- 6 November 2035Patent 10039804 drug product
- 6 November 2035Patent 10188697 drug product
- 6 November 2035Patent 10849956 drug product
- 6 November 2035Patent 12161690 drug product
- 6 November 2035Patent 11628200 drug product
For Solution, Oral
One to three generic makers listed
Brand listed as marketed: Firvanq Kit. 3 generic makers with 5 generic products listed as marketed; the first generic approval is dated 13 July 1983.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Ani Pharmaceuticals Inc | 13 July 1983 | 1 |
| Alkem Laboratories Ltd | 14 November 2022 | 2 |
| Aurobindo Pharma Ltd | 7 August 2026 | 2 |
Patents and exclusivities still listed
- 13 March 2035Patent 10959947 drug product
- 13 March 2035Patent 10959948 drug product
- 13 March 2035Patent 10959949 drug product
- 13 March 2035Patent 10688046 drug product
- 13 March 2035Patent 10959946 drug product
- 13 March 2035Patent 10493028 drug product
- 13 March 2035Patent 11638692 drug product
Powder, Intravenous, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Vancomycin Hydrochloride. 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.