Generic competition · all medicines · read 12 November 2026
Is there a generic of Nitroglycerin, and who makes it?
Nitroglycerin appears in 9 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 between 1.4 and 16.7 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.
- Nitroglycerin appears in 9 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 between 1.4 and 16.7 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, Sublingual
Four or more generic makers listed
Brand listed as marketed: Nitrostat. 7 generic makers with 21 generic products listed as marketed; the first generic approval is dated 26 August 2016.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Dr Reddys Laboratories Inc | 26 August 2016 | 3 |
| Glenmark Specialty Sa | 19 September 2017 | 3 |
| Natco Pharma Ltd | 30 April 2019 | 3 |
| Rubicon Research Ltd | 3 May 2021 | 3 |
| Aurobindo Pharma Ltd | 26 October 2023 | 3 |
| Mankind Pharma Ltd | 5 December 2023 | 3 |
| Pharmobedient Consulting Llc | 15 October 2024 | 3 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Film, Extended Release, Transdermal
One to three generic makers listed
Brand listed as marketed: Nitro-Dur. 2 generic makers with 8 generic products listed as marketed; the first generic approval is dated 30 August 1996.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Mylan Technologies Inc | 30 August 1996 | 4 |
| Zydus Pharmaceuticals Usa Inc | 30 October 1998 | 4 |
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: Nitroglycerin In Dextrose 5%. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 10 September 1985.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| American Regent Inc | 24 May 1988 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Ointment, Intra-Anal
Four or more generic makers listed
Every brand product here is listed as discontinued. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 16 February 2024.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Cosette Pharmaceuticals Nc Laboratories Llc | 16 February 2024 | 1 |
| Tp Anda Holdings Llc | 29 November 2024 | 1 |
| Encube Ethicals Private Ltd | 16 December 2024 | 1 |
| Amvika Pharma Llc | 18 December 2025 | 1 |
| Padagis Israel Pharmaceuticals Ltd | 6 July 2026 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Spray, Metered, Sublingual
One to three generic makers listed
Brand listed as marketed: Nitrolingual Pumpspray. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 20 September 2013.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Padagis Israel Pharmaceuticals Ltd | 20 September 2013 | 1 |
| Epic Pharma Llc | 21 August 2026 | 1 |
Patents and exclusivities still listed
- 12 March 2029Patent 7872049 drug product
Ointment, Transdermal
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 8 July 1988.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fougera Pharmaceuticals Inc | 8 July 1988 | 1 |
| Encube Ethicals Private Ltd | 15 April 2025 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Aerosol, Metered, Sublingual
Brand listed, no generic listed as marketed
Brand listed as marketed: Nitromist. 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.
Aerosol, Sublingual
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.
Powder, Sublingual
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.