Phenylephrine
As of the edition of 20 October 2026, Phenylephrine is a small molecule: marketed, first approved in 1960 (ES); acts on ADRA1A, ADRA1B and ADRA1D; 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 2015
- Kind
- Small molecule
- Brand name
- Duo-Medihaler
- First approved
- 1 June 1960 (ES)
- Approvals on record
- 37 in 5 regions
- Holder of the most recent approval
- Dr. Reddy's; 17 holders in all
- Registered trials
- 151, 21 stopped early
- Disease areas
- Heart and blood vessels; Lungs and airways; Infections; Eye; Nervous system; Ear, nose and throat
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.
Eyenovia holds a later exclusivity on its own new formulation or combination product, which ended in 2026; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Phenylephrine.
See the 6 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 51 | 28 | 6 | 7 |
| Phase 1 | 18 | 11 | 1 | 4 |
| Phase 2 | 15 | 9 | 2 | 3 |
| Phase 3 | 23 | 14 | 1 | 4 |
| Phase 4 | 44 | 30 | 4 | 3 |
| All trials | 151 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Applicant | 1979 to now |
| Bausch Health | Later holder | 1995 to now |
| Johnson & Johnson | Later holder and Lead sponsor of trials | 2006 to now |
| Hikma Pharmaceuticals | Applicant, Later holder and Lead sponsor of trials | 2012 to now |
| Paragon Bioteck | Later holder | 2013 to now |
| Reckitt Benckiser | Later holder | 2014 to now |
| Akorn | Later holder | 2015 to now |
| Rayner Surgical | Applicant | 2015 to now |
| Eton Pharmaceuticals | Later holder | 2019 to now |
| Exela Pharma Sciences | Acquired holder | 2020 to now |
| Dr. Reddy's | Acquired holder | 2022 to now |