Pantoprazole
As of the edition of 20 October 2026, Pantoprazole is a small molecule: marketed, first approved in 1995 (FR); acts on ATP4A; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Protonix
- First approved
- 8 February 1995 (FR)
- Approvals on record
- 23 in 7 regions
- Holder of the most recent approval
- Baxter Healthcare; 5 holders in all
- Withdrawn from market
- 19 September 2016 (in some regions)
- Registered trials
- 132, 14 stopped early
- Disease areas
- Digestive system; Heart and blood vessels; Cancer; Nutrition and metabolism; Nervous system; Lungs and airways
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. The application that gives this date is held by Pfizer.
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.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Pantoprazole.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ATP4A | Potassium-transporting ATPase alpha chain 1 | P20648 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 27 | 17 | 2 | 2 |
| Phase 1 | 33 | 29 | 3 | 1 |
| Phase 2 | 12 | 7 | 3 | 0 |
| Phase 3 | 21 | 12 | 1 | 4 |
| Phase 4 | 39 | 29 | 0 | 7 |
| All trials | 132 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant and Lead sponsor of trials | 1997 to now |
| Pfizer | Applicant and Lead sponsor of trials | 2000 to now |
| Exela Pharma Sciences | Later holder | 2017 to now |
| Hikma Pharmaceuticals | Acquired holder | 2019 to now |
| Baxter Healthcare | Later holder | 2024 to now |