Generic competition · all medicines · read 12 November 2026
Is there a generic of Albuterol Sulfate, and who makes it?
Albuterol Sulfate appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 20 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 4.9 and 23.5 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.
- Albuterol Sulfate appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 20 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 4.9 and 23.5 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. 5 generic makers with 10 generic products listed as marketed; the first generic approval is dated 5 December 1989.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Sun Pharmaceutical Industries Inc | 5 December 1989 | 2 |
| Amneal Pharmaceuticals Co Gmbh | 21 May 2018 | 2 |
| Rising Pharma Holdings Inc | 29 June 2018 | 2 |
| Acertis Pharmaceuticals Llc | 26 October 2018 | 2 |
| Zydus Pharmaceuticals Usa Inc | 22 October 2020 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Inhalation
Four or more generic makers listed
Every brand product here is listed as discontinued. 6 generic makers with 15 generic products listed as marketed; the first generic approval is dated 27 November 1991.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Nephron Pharmaceuticals Corp | 17 September 1997 | 4 |
| Sentiss Ag | 15 January 1998 | 1 |
| The Ritedose Corp | 16 December 2008 | 4 |
| Sun Pharmaceutical Industries Ltd | 21 July 2017 | 1 |
| Luoxin Aurovitas Pharma Chengdu Co Ltd | 17 October 2017 | 3 |
| Lexenpharm Suzhou Ltd | 3 May 2024 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Syrup, Oral
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 30 March 1992.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Usa Inc | 30 March 1992 | 1 |
| Chartwell Molecular Holdings Llc | 27 December 2006 | 1 |
| Chartwell Rx Sciences Llc | 26 June 2007 | 1 |
| Amneal Pharmaceuticals | 12 May 2010 | 1 |
| Quagen Pharmaceuticals Llc | 6 September 2019 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Aerosol, Metered, Inhalation
Four or more generic makers listed
Brand listed as marketed: Proair Hfa, Proventil-Hfa and Ventolin Hfa. 6 generic makers with 7 generic products listed as marketed; the first generic approval is dated 24 February 2020.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Padagis Us Llc | 24 February 2020 | 1 |
| Cipla Ltd | 8 April 2020 | 2 |
| Lupin Inc | 24 August 2020 | 1 |
| Sandoz Inc | 1 June 2021 | 1 |
| Armstrong Pharmaceuticals Inc | 21 May 2024 | 1 |
| Amneal Ireland Ltd | 1 December 2025 | 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 (4 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.
Powder, Metered, Inhalation
Brand listed, no generic listed as marketed
Brand listed as marketed: Proair Respiclick. 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.
Capsule, Inhalation
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.