Soybean oil
As of the edition of 20 October 2026, Soybean oil is a drug: marketed, first approved in 1982 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Unknown
- Brand name
- Intralipid 20%
- First approved
- 1 January 1982 (US)
- Approvals on record
- 33 in 2 regions
- Holder of the most recent approval
- Fresenius Kabi; 7 holders in all
- Registered trials
- 14, 3 stopped early
- Disease areas
- Nutrition and metabolism; Digestive system; Hormones; Urinary and reproductive; Infections; Heart and blood vessels
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 4 | 0 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 1 | 1 | 0 |
| Phase 3 | 2 | 1 | 0 | 1 |
| Phase 4 | 2 | 1 | 0 | 1 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Baxter Healthcare | Later holder | 1982 to now |
| Abbott | Later holder | 1984 to now |
| B. Braun Medical | Later holder | 1993 to now |
| Fresenius Kabi | Later holder | 1996 to now |
| Alpha Therapeutic | Acquired holder | 2003 to now |
| Fresenius Kabi Deutschland | Acquired holder | 2005 to now |
| Pfizer | Acquired holder and Earlier holder | 2005 to now |