Pancreatin
As of the edition of 20 October 2026, Pancreatin is a drug: marketed, first approved in 1987 (FR); US protection ended in 2008.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Unknown
- Brand name
- Cotazym
- First approved
- 22 April 1987 (FR)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- AbbVie; 5 holders in all
- Registered trials
- 25, 4 stopped early
- Disease areas
- Digestive system; Inherited and neonatal; Lungs and airways; Nutrition and metabolism; Cancer; Hormones
US protection
US protection ended in 2008.
US protection ended in 2008, 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 Organon. 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 | 5 | 4 | 0 | 1 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 8 | 6 | 0 | 1 |
| Phase 4 | 9 | 5 | 1 | 2 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Applicant and Lead sponsor of trials | 2008 to now |