Gemcitabine
As of the edition of 20 October 2026, Gemcitabine is a small molecule: marketed, first approved in 1996 (US); acts on RRM1; 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 2019
- Kind
- Small molecule
- Brand name
- Gemzar
- First approved
- 15 May 1996 (US)
- Approvals on record
- 33 in 5 regions
- Holder of the most recent approval
- Johnson & Johnson; 8 holders in all
- Registered trials
- 2,390, 410 stopped early
- Disease areas
- Cancer; Digestive system; Hormones; Lungs and airways; Urinary and reproductive; Pregnancy and women's health
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.
Johnson & Johnson holds a later exclusivity on its own new formulation or combination product, ending 2028; 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 Gemcitabine.
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 |
|---|---|---|
| RRM1 | Ribonucleoside-diphosphate reductase large subunit | P23921 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 66 | 19 | 20 | 11 |
| Phase 1 | 460 | 264 | 62 | 101 |
| Phase 2 | 1,495 | 747 | 313 | 247 |
| Phase 3 | 353 | 133 | 103 | 48 |
| Phase 4 | 16 | 1 | 4 | 3 |
| All trials | 2,390 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Applicant and Lead sponsor of trials | 1996 to now |
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 1999 to now |
| Johnson & Johnson | Later holder and Lead sponsor of trials | 1999 to now |
| Accord Healthcare | Later holder | 2017 to now |
| SUN Pharmaceutical Industries | Later holder | 2018 to now |
| Avyxa | Later holder | 2025 to now |