Oxybutynin
As of the edition of 20 October 2026, Oxybutynin is a small molecule: marketed, first approved in 1982 (US); acts on CHRM3; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Ditropan
- First approved
- 1 January 1982 (US)
- Approvals on record
- 15 in 5 regions
- Holder of the most recent approval
- Hisamitsu Pharmaceutical; 8 holders in all
- Registered trials
- 60, 2 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Nervous system; Skin and connective tissue; Lungs and airways; Inherited and neonatal
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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Oxybutynin.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CHRM3 | Muscarinic acetylcholine receptor M3 | P20309 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 10 | 1 | 0 |
| Phase 1 | 11 | 10 | 0 | 0 |
| Phase 2 | 12 | 7 | 2 | 0 |
| Phase 3 | 14 | 8 | 4 | 1 |
| Phase 4 | 11 | 9 | 1 | 1 |
| All trials | 60 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Acquired holder, Later holder and Lead sponsor of trials | 1995 to now |
| Actavis | Later holder and Lead sponsor of trials | 2003 to now |
| Teva | Applicant | 2004 to now |
| Halozyme Therapeutics | Later holder and Lead sponsor of trials | 2009 to now |
| AbbVie | Acquired holder and Lead sponsor of trials | 2011 to now |
| Merck & Co. | Later holder | 2013 to now |
| Hisamitsu Pharmaceutical | Applicant | 2013 to now |
| Sanofi | Later holder |