Pancrelipase
As of the edition of 20 October 2026, Pancrelipase is an enzyme: marketed, first approved in 1996 (US); 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
- Enzyme
- Brand name
- Cotazym
- First approved
- 9 December 1996 (US)
- Approvals on record
- 27 in 2 regions
- Holder of the most recent approval
- Aimmune Therapeutics; 7 holders in all
- Registered trials
- 25, 6 stopped early
- Disease areas
- Digestive system; Inherited and neonatal; Lungs and airways; Cancer; Hormones; Nutrition and metabolism
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 | 3 | 1 | 1 |
| Phase 2 | 5 | 0 | 3 | 2 |
| Phase 3 | 8 | 8 | 0 | 0 |
| Phase 4 | 7 | 3 | 1 | 3 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Applicant | 1996 to now |
| Actavis | Later holder and Lead sponsor of trials | 2006 to now |
| Solvay Pharmaceuticals | Later holder and Lead sponsor of trials | 2007 to now |
| Digestive Care | Later holder and Lead sponsor of trials | 2008 to now |
| Johnson & Johnson | Later holder | 2010 to now |
| AbbVie | Acquired holder and Lead sponsor of trials | 2012 to now |
| Viokace | Acquired holder | 2020 to now |
| Vivus | Acquired holder | 2022 to now |
| Aimmune Therapeutics | Acquired holder | 2026 to now |