Famotidine
As of the edition of 20 October 2026, Famotidine is a small molecule: marketed, first approved in 1986 (US); acts on HRH2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- Pepcid
- First approved
- 15 October 1986 (US)
- Approvals on record
- 23 in 3 regions
- Holder of the most recent approval
- Nichi-Iko Pharmaceutical; 9 holders in all
- Registered trials
- 88, 14 stopped early
- Disease areas
- Lungs and airways; Infections; Cancer; Immune system; Digestive system; Skin and connective tissue
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 Famotidine.
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 |
|---|---|---|
| HRH2 | Histamine H2 receptor | P25021 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 9 | 1 | 0 |
| Phase 1 | 43 | 34 | 5 | 4 |
| Phase 2 | 14 | 4 | 4 | 5 |
| Phase 3 | 9 | 5 | 1 | 2 |
| Phase 4 | 12 | 7 | 2 | 3 |
| All trials | 88 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Earlier holder | 1986 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 1995 to now |
| UCB | Later holder | 2004 to now |
| Johnson & Johnson | Acquired holder and Lead sponsor of trials | 2020 to now |
| Bausch Health | Acquired holder | 2021 to now |
| Kenvue Brands | Acquired holder | 2025 to now |
| Nichi-Iko Pharmaceutical | Later holder | 2025 to now |