Calfactant
As of the edition of 20 October 2026, Calfactant is a drug: marketed, first approved in 1998 (US); US protection ended in 2010.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Unknown
- Brand name
- Infasurf
- First approved
- 1 July 1998 (US)
- Approvals on record
- 3 in 1 region
- Holder of the most recent approval
- ONY Biotech; 2 holders in all
- Registered trials
- 11, 2 stopped early
- Disease areas
- Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Inherited and neonatal; Cancer; Digestive system
US protection
US protection ended in 2010.
US protection ended in 2010, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by ONY Biotech. The date is computed, not published.
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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 3 | 0 | 0 |
| Phase 2 | 4 | 1 | 1 | 1 |
| Phase 3 | 4 | 2 | 0 | 1 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ony | Applicant and Lead sponsor of trials | 1998 to now |
| ONY Biotech | Acquired holder | 2020 to now |