Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). Sold as Protonix, Protonix Iv, Pantoprazole Sodium, Pantoprazole Sodium In 0.9% Sodium Chloride. Every FDA application for this active ingredient: 6 branded and 42 generic.
As of Nov 15, 2026, FDA lists 48 applications for Pantoprazole Sodium (sold as Protonix, Protonix Iv, Pantoprazole Sodium and others), first approved Feb 2, 2000, with 6 new uses approved and 0 published complete response letters.
| Pantoprazole Sodium | Part D | $329M | +3% | 7,147,609 |
| Protonix | Part D | $9.6M | -10% | 2,966 |
| Protonix IV | Part D | $19K | -36% | 45 |
| Feb 2, 2000 | ProtonixNDA 20987 · New molecular entity | Wyeth Pharms | 43 | Discontinued |
| Dec 6, 2004 | Protonix IvNDA 20988 | Wyeth Pharms | 50 | Marketed |
| Aug 2, 2007 | Pantoprazole SodiumANDA 77056 | Teva | 17 | Discontinued |
| Sep 10, 2007 | Pantoprazole SodiumANDA 77058 | Sun Pharm | 8 | Discontinued |
| Nov 14, 2007 | ProtonixNDA 22020 · New dosage form | Wyeth Pharms | 17 | Discontinued |
| Jan 19, 2011 | Pantoprazole SodiumANDA 77619 | Dr Reddys Labs Ltd | 15 | Marketed |
| Jan 19, 2011 | Pantoprazole SodiumANDA 90970 | Mylan Pharms Inc | 13 | Marketed |
| Jan 19, 2011 | Pantoprazole SodiumANDA 91231 | Apotex | 1 | Marketed |
| Jan 19, 2011 | Pantoprazole SodiumANDA 90074 | Torrent Pharms | 13 | Marketed |
| Jan 20, 2011 | Pantoprazole SodiumANDA 78281 | Lannett Co Inc | 18 | Marketed |
| Feb 7, 2011 | Pantoprazole SodiumANDA 90797 | Actavis Totowa | 10 | Discontinued |
| Aug 30, 2011 | Pantoprazole SodiumANDA 90901 | Jubilant Generics | 10 | Discontinued |
| Feb 16, 2012 | Pantoprazole SodiumANDA 200821 | Macleods Pharms Ltd | 13 | Discontinued |
| May 2, 2012 | Pantoprazole SodiumANDA 90807 | Rubicon Research | 10 | Marketed |
| May 2, 2012 | Pantoprazole SodiumANDA 200794 | Sun Pharm Inds Ltd | 5 | Discontinued |
| Sep 28, 2012 | Pantoprazole SodiumANDA 202038 | Aurobindo Pharma Ltd | 13 | Marketed |
| Nov 8, 2012 | Pantoprazole SodiumANDA 79197 | Epic Pharma LLC | 5 | Marketed |
| May 7, 2014 | Pantoprazole SodiumANDA 203024 | L Perrigo Co | 0 | Discontinued |
| Sep 10, 2014 | Pantoprazole SodiumANDA 202882 | Hetero Labs Ltd V | 3 | Marketed |
| Dec 2, 2014 | Pantoprazole SodiumANDA 202052 | Orbion Pharms | 9 | Marketed |
| Jul 14, 2015 | Pantoprazole SodiumANDA 90296 | Sandoz | 9 | Discontinued |
| Jan 26, 2016 | Pantoprazole SodiumANDA 205119 | Amneal Pharms | 9 | Marketed |
| Mar 30, 2016 | Pantoprazole SodiumANDA 205675 | Eugia Pharma | 12 | Marketed |
| Jun 30, 2017 | Pantoprazole SodiumNDA 209463 · New formulation or manufacturer | Hikma | 5 | Marketed |
| May 4, 2018 | Pantoprazole SodiumANDA 208580 | Pharmobedient | 7 | Discontinued |
| Mar 1, 2019 | Pantoprazole SodiumANDA 211368 | Ingenus Pharms LLC | 4 | Discontinued |
| Aug 19, 2019 | Pantoprazole SodiumANDA 77674 | Sun Pharm | 5 | Discontinued |
| Jun 30, 2020 | Pantoprazole SodiumANDA 213725 | Sun Pharm | 3 | Marketed |
| Aug 30, 2021 | Pantoprazole SodiumANDA 209524 | Hangzhou Zhongmei | 2 | Marketed |
| May 18, 2022 | Pantoprazole SodiumANDA 204400 | Gland | 2 | Marketed |
| May 18, 2022 | Pantoprazole SodiumANDA 213778 | Aspiro | 3 | Marketed |
| May 18, 2022 | Pantoprazole SodiumANDA 216171 | Be Pharms | 1 | Marketed |
| May 19, 2022 | Pantoprazole SodiumANDA 214680 | Knack | 2 | Marketed |
| Jul 26, 2022 | Pantoprazole SodiumANDA 215880 | Mankind Pharma | 1 | Marketed |
| Aug 29, 2022 | Pantoprazole SodiumANDA 215860 | Meitheal | 3 | Marketed |
| Feb 9, 2023 | Pantoprazole SodiumANDA 217416 | Ajanta Pharma Ltd | 1 | Marketed |
| Jun 16, 2023 | Pantoprazole SodiumANDA 216247 | Dexcel | 2 | Marketed |
| Oct 27, 2023 | Pantoprazole SodiumANDA 216139 | Annora Pharma | 0 | Marketed |
| Dec 11, 2023 | Pantoprazole SodiumANDA 217282 | Granules | 0 | Marketed |
| Feb 14, 2024 | Pantoprazole Sodium In 0.9% Sodium ChlorideNDA 217512 · New dosage form | Baxter Hlthcare Corp | 0 | Marketed |
| Aug 1, 2024 | Pantoprazole SodiumANDA 216021 | Fresenius Kabi USA | 0 | Marketed |
| Jan 16, 2025 | Pantoprazole SodiumANDA 219087 | Graviti Pharms | 0 | Marketed |
| Mar 31, 2025 | Pantoprazole SodiumANDA 217458 | Cipla | 0 | Marketed |
| Mar 31, 2025 | Pantoprazole SodiumANDA 217923 | Aurobindo Pharma Ltd | 0 | Marketed |
| Mar 31, 2025 | Pantoprazole SodiumANDA 219230 | Alembic | 0 | Marketed |
| May 16, 2025 | Pantoprazole SodiumANDA 215074 | Deva Holding As | 0 | Marketed |
| Apr 22, 2026 | Pantoprazole SodiumANDA 219973 | Shuangcheng | 0 | Marketed |
| — | Pantoprazole SodiumNDA 22226 | Teva Parenteral | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA