Pilocarpine
As of the edition of 20 October 2026, Pilocarpine is a small molecule: marketed, first approved in 1928 (ES); acts on CHRM1; 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 1982
- Kind
- Small molecule
- Brand name
- Ocusert PILO-20
- First approved
- 1 October 1928 (ES)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- Orasis Pharmaceuticals; 11 holders in all
- Registered trials
- 40, 2 stopped early
- Disease areas
- Eye; Mouth and teeth; Cancer; Nervous system; Urinary and reproductive; Digestive system
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.
Orasis Pharmaceuticals 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
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 Pilocarpine.
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 |
|---|---|---|
| CHRM1 | Muscarinic acetylcholine receptor M1 | P11229 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 9 | 1 | 1 |
| Phase 1 | 5 | 2 | 0 | 0 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 15 | 10 | 1 | 1 |
| Phase 4 | 3 | 1 | 1 | 0 |
| All trials | 40 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant | 1959 to now |
| OmniVision | Applicant | 1960 to now |
| Alcon | Later holder | 1984 to now |
| Eisai | Later holder | 1994 to now |
| Bausch Health | Later holder | 1995 to now |
| AbbVie | Later holder and Lead sponsor of trials | 2018 to now |
| Orasis Pharmaceuticals | Later holder | 2023 to now |
| Sandoz | Acquired holder | 2023 to now |
| Epic Pharma | Acquired holder | 2023 to now |
| Advanz Pharma | Acquired holder | 2025 to now |
| Johnson & Johnson | Applicant |