Generic competition · all medicines · read 12 November 2026
Is there a generic of Diazepam, and who makes it?
Diazepam appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 17 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 25.8 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.
- Diazepam appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 17 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 25.8 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
Brand listed as marketed: Valium. 5 generic makers with 15 generic products listed as marketed; the first generic approval is dated 4 September 1985.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Mylan Pharmaceuticals Inc | 4 September 1985 | 3 |
| Nuvo Pharmaceutical Inc | 25 February 1986 | 3 |
| Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa | 10 December 1986 | 3 |
| Dr Reddys Laboratories Sa | 3 February 1987 | 3 |
| Aurobindo Pharma Ltd | 14 December 2023 | 3 |
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
Every brand product here is listed as discontinued. 10 generic makers with 14 generic products listed as marketed; the first generic approval is dated 16 December 1985.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 16 December 1985 | 2 |
| Hospira Inc | 13 October 1987 | 2 |
| Regcon Holdings Llc | 18 March 2019 | 2 |
| Fresenius Kabi Usa Llc | 10 November 2022 | 1 |
| Alembic Pharmaceuticals Ltd | 25 April 2024 | 1 |
| Dr Reddys Laboratories Ltd | 18 July 2024 | 1 |
| Long Grove Pharmaceuticals Llc | 31 December 2024 | 1 |
| Galenicum Health Slu | 19 May 2025 | 1 |
| Lupin Ltd | 27 July 2026 | 1 |
| Baxter Healthcare Corp | 28 July 2026 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Gel, Rectal
One to three generic makers listed
Brand listed as marketed: Diastat and Diastat Acudial. 2 generic makers with 5 generic products listed as marketed; the first generic approval is dated 30 May 2023.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Novel Laboratories Inc | 30 May 2023 | 2 |
| Navinta Llc | 14 November 2025 | 3 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Spray, Nasal
Brand listed, no generic listed as marketed
Brand listed as marketed: Valtoco. No generic is listed as marketed.
Patents and exclusivities still listed
- 10 January 2027Exclusivity ODE-279 Valtoco
- 15 April 2028Exclusivity NPP Valtoco
- 27 March 2029Patent 12521400 drug product
- 27 March 2029Patent 11793786 drug product
- 27 March 2029Patent 12268664 drug product
- 27 March 2029Patent 8895546 drug product
- 27 March 2029Patent 11241414 drug product
- 13 June 2032Patent 12337061
- 16 October 2032Patent 12324852
- 10 June 2042Patent 12599611
Concentrate, Oral
Generics listed, no brand listed
No brand application is listed. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 3 April 1987.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 3 April 1987 | 1 |
| Chartwell Molecular Holdings Llc | 14 April 2014 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Oral
Generics listed, no brand listed
No brand application is listed. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 3 April 1987.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 3 April 1987 | 1 |
| Chartwell Molecular Holdings Llc | 24 June 2016 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Capsule, Extended Release, Oral
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.