Pemetrexed
As of the edition of 20 October 2026, Pemetrexed is a small molecule: marketed, first approved in 2004 (US); acts on DHFR, GART and TYMS; 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 2017
- Kind
- Small molecule
- Brand name
- Alimta
- First approved
- 4 February 2004 (US)
- Approvals on record
- 34 in 5 regions
- Holder of the most recent approval
- Avyxa; 13 holders in all
- Withdrawn from market
- 2 May 2025 (in some regions)
- Registered trials
- 952, 173 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Urinary and reproductive; Nervous system; 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.
Eagle Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2035; 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 Pemetrexed.
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 | 26 | 8 | 8 | 1 |
| Phase 1 | 170 | 90 | 37 | 35 |
| Phase 2 | 576 | 225 | 153 | 114 |
| Phase 3 | 165 | 57 | 63 | 20 |
| Phase 4 | 15 | 5 | 1 | 3 |
| All trials | 952 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Originator, Applicant and Lead sponsor of trials | 2001 to now |
| Pfizer | Later holder and Lead sponsor of trials | 2005 to now |
| Actavis | Later holder | 2016 to now |
| Eagle Pharmaceuticals | Later holder | 2020 to now |
| Actavis Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals | Later holder | 2020 to now |
| Sandoz | Later holder | 2022 to now |
| Accord Healthcare | Later holder | 2022 to now |
| Shilpa Medicare | Later holder | 2023 to now |
| Avyxa | Later holder | 2024 to now |
| Nippon Kayaku | Applicant |