Albuterol
As of the edition of 20 October 2026, Albuterol is a small molecule: marketed, first approved in 1972 (CH); acts on ADRB2; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Small molecule
- Brand name
- Proventil
- First approved
- 19 May 1972 (CH)
- Approvals on record
- 41 in 5 regions
- Holder of the most recent approval
- AstraZeneca; 12 holders in all
- Registered trials
- 262, 31 stopped early
- Disease areas
- Lungs and airways; Immune system; Inherited and neonatal; Nutrition and metabolism; Nervous system; Infections
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
AstraZeneca holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Albuterol.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ADRB2 | Beta-2 adrenergic receptor | P07550 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 59 | 33 | 5 | 4 |
| Phase 1 | 33 | 25 | 2 | 3 |
| Phase 2 | 33 | 27 | 1 | 3 |
| Phase 3 | 75 | 55 | 3 | 12 |
| Phase 4 | 62 | 44 | 5 | 9 |
| All trials | 262 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant, Acquired holder and Lead sponsor of trials | 1972 to now |
| Muro Pharmaceutical | Later holder | 1992 to now |
| 3M | Later holder | 1996 to now |
| Bausch Health | Acquired holder | 1997 to now |
| Boehringer Ingelheim | Later holder and Lead sponsor of trials | 1997 to now |
| Viatris | Later holder and Lead sponsor of trials | 2001 to now |
| Ivax | Later holder | 2004 to now |
| Teva | Acquired holder and Lead sponsor of trials | 2006 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2015 to now |
| Kindeva Drug Delivery | Acquired holder | 2020 to now |
| Pharmobedient Consulting | Acquired holder | 2025 to now |