Orphenadrine
As of the edition of 20 October 2026, Orphenadrine is a small molecule: marketed, first approved in 1982 (US); acts on HRH1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1994
- Kind
- Small molecule
- Brand name
- Norflex
- First approved
- 1 January 1982 (US)
- Approvals on record
- 6 in 2 regions
- Holder of the most recent approval
- Sterimax; 4 holders in all
- Registered trials
- 7, 1 stopped early
- Disease areas
- Nervous system; Digestive system; Bones, joints and muscles; Cancer
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this 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 Orphenadrine.
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 |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 1 |
| Phase 3 | 2 | 0 | 1 | 0 |
| Phase 4 | 4 | 3 | 0 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sterimax | Applicant | 1994 to now |
| Bausch Health | Acquired holder | 2021 to now |
| Pharmaceutical Associates | Acquired holder | 2022 to now |
| 3M | Applicant and Later holder |