Diclofenac
As of the edition of 20 October 2026, Diclofenac is a small molecule: marketed, first approved in 1974 (CH); acts on PTGS1 and PTGS2; 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 2021
- Kind
- Small molecule
- Brand name
- Voltaren
- First approved
- 11 January 1974 (CH)
- Approvals on record
- 45 in 7 regions
- Holder of the most recent approval
- IBSA Institut Biochimique; 18 holders in all
- Registered trials
- 234, 17 stopped early
- Disease areas
- Bones, joints and muscles; Injuries; Nervous system; Cancer; Skin and connective tissue; Mouth and teeth
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.
IBSA Institut Biochimique holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
7 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product7 company-target rows are on route B because of Diclofenac.
See the 7 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 53 | 30 | 8 | 6 |
| Phase 1 | 37 | 30 | 4 | 0 |
| Phase 2 | 22 | 18 | 1 | 1 |
| Phase 3 | 73 | 63 | 2 | 5 |
| Phase 4 | 49 | 38 | 0 | 5 |
| All trials | 234 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 1985 to now |
| GEIGY Pharmaceuticals | Applicant | 1988 to now |
| IBSA Institut Biochimique | Applicant and Lead sponsor of trials | 1991 to now |
| Pfizer | Later holder and Lead sponsor of trials | 1993 to now |
| Alcon | Later holder | 1998 to now |
| Nuvo | Later holder and Lead sponsor of trials | 2004 to now |
| Xanodyne Pharmaceutics | Later holder | 2009 to now |
| Iroko Pharmaceuticals | Later holder and Lead sponsor of trials | 2009 to now |
| Almirall | Later holder and Lead sponsor of trials | 2010 to now |
| Thea Pharma | Later holder | 2011 to now |
| Javelin Pharmaceuticals Inc A Wholly Owned Sudsidiary Of Hospira | Later holder | 2014 to now |
| Nuvo-Group | Acquired holder | 2017 to now |
| Zydus Worldwide DMCC | Acquired holder | 2019 to now |
| Amgen | Acquired holder | 2020 to now |
| Hisamitsu Pharmaceutical | Applicant | 2021 to now |
| Haleon | Acquired holder and Lead sponsor of trials | 2024 to now |
| Cosette Pharmaceuticals | Acquired holder | 2026 to now |
| Fougera Pharmaceuticals | Acquired holder | 2026 to now |