Meloxicam
As of the edition of 20 October 2026, Meloxicam is a small molecule: marketed, first approved in 1995 (FR); acts on 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 2010
- Kind
- Small molecule
- Brand name
- Mobic
- First approved
- 8 May 1995 (FR)
- Approvals on record
- 19 in 4 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 11 holders in all
- Withdrawn from market
- 5 October 2023 (in some regions)
- Registered trials
- 88, 9 stopped early
- Disease areas
- Bones, joints and muscles; Immune system; Skin and connective tissue; Nervous system; Cancer; Infections
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.
Nanjing Delova Biotech holds a later exclusivity on its own new formulation or combination product, ending 2040; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Meloxicam.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PTGS2 | Prostaglandin G/H synthase 2 | P35354 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 11 | 11 | 0 | 0 |
| Phase 1 | 23 | 20 | 1 | 0 |
| Phase 2 | 14 | 10 | 0 | 2 |
| Phase 3 | 28 | 20 | 0 | 4 |
| Phase 4 | 12 | 7 | 2 | 3 |
| All trials | 88 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Applicant and Lead sponsor of trials | 1998 to now |
| Iroko Pharmaceuticals | Later holder and Lead sponsor of trials | 2013 to now |
| Eurofarma Laboratorios | Applicant and Lead sponsor of trials | 2013 to now |
| Baudax Bio | Later holder and Lead sponsor of trials | 2015 to now |
| TerSera Therapeutics | Later holder | 2018 to now |
| Avondale Pharmaceuticals | Acquired holder | 2019 to now |
| Iceutica | Acquired holder | 2022 to now |
| Nanjing Delova Biotech | Later holder | 2025 to now |
| Azurity Pharmaceuticals | Later holder | 2025 to now |