Acyclovir
As of the edition of 20 October 2026, Acyclovir is a small molecule: marketed, first approved in 1982 (US); 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 2006
- Kind
- Small molecule
- Brand name
- Zovirax
- First approved
- 29 March 1982 (US)
- Approvals on record
- 39 in 7 regions
- Holder of the most recent approval
- Aché Laboratórios Farmacêuticos; 21 holders in all
- Registered trials
- 70, 1 stopped early
- Disease areas
- Infections; Immune system; Urinary and reproductive; Skin and connective tissue; Pregnancy and women's health; Nervous 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.
Fera 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 20 | 13 | 2 | 0 |
| Phase 1 | 8 | 5 | 2 | 0 |
| Phase 2 | 13 | 13 | 0 | 0 |
| Phase 3 | 23 | 17 | 1 | 1 |
| Phase 4 | 6 | 5 | 0 | 0 |
| All trials | 70 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Earlier holder | 1982 to now |
| Fera Pharmaceuticals | Later holder | 2019 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2023 to now |
| Ligand Pharmaceuticals | Acquired holder | 2025 to now |
| Pharmobedient Consulting | Acquired holder | 2025 to now |
| Mitsubishi Tanabe Pharma | Applicant | |
| Nippon Kayaku | Later holder | |
| Sawai Pharmaceutical | Later holder |