Sugammadex
As of the edition of 20 October 2026, Sugammadex is an oligosaccharide: marketed, first approved in 2008 (EU); US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Oligosaccharide
- Brand name
- Bridion
- First approved
- 25 July 2008 (EU)
- Approvals on record
- 8 in 6 regions
- Holder of the most recent approval
- Laboratoire Aguettant; 3 holders in all
- Registered trials
- 171, 5 stopped early
- Disease areas
- Nervous system; Cancer; Digestive system; Lungs and airways; Urinary and reproductive; Nutrition and metabolism
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Merck & Co..
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product6 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 49 | 27 | 8 | 0 |
| Phase 1 | 5 | 3 | 0 | 1 |
| Phase 2 | 17 | 14 | 1 | 0 |
| Phase 3 | 31 | 28 | 2 | 0 |
| Phase 4 | 69 | 51 | 1 | 4 |
| All trials | 171 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 2002 to now |
| Organon | Applicant | 2015 to now |
| Extrovis | Later holder | 2023 to now |