Manages renal tubular acidosis. Sold as Urocit-K, Potassium Citrate. Every FDA application for this active ingredient: 2 branded and 9 generic.
As of Nov 15, 2026, FDA lists 11 applications for Potassium Citrate (sold as Urocit-K, Potassium Citrate), first approved Aug 30, 1985, with 0 new uses approved and 0 published complete response letters.
| Potassium Citrate ER | Part D | $41.1M | -18% | 156,920 |
| Urocit-K | Part D | $76K | -19% | 54 |
| Optimizing H. Pylori Eradication Regimen Under Intensified Acid SuppressionHELICOBACTER PYLORI INFECTIONS · Qilu Hospital of Shandong University | Phase 4 | Not yet recruiting | Aug 6, 2026 |
| Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic StrokeIschemic Stroke, Transient Ischemic Attack · Asan Medical Center | Phase 3 | Not yet recruiting | Jul 28, 2026 |
| The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter PyloriHELICOBACTER PYLORI INFECTIONS · Xuanzhu Biopharmaceutical Co., Ltd. | Phase 3 | Not yet recruiting | May 26, 2026 |
| Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute Myocardial InfarctionAcute Myocardial Infarction (AMI), Gastrointestinal Bleeding · Samsung Medical Center | Phase 3 | Recruiting | Mar 12, 2026 |
| Fecal Molecular Susceptibility-guided Hp Rescue TherapyHelicobacter Pylori Infection · Shanghai Zhongshan Hospital | Phase 4 | Not yet recruiting | Feb 12, 2026 |
| Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney StonesKidney Stones, Urolithiasis, Hypocitraturia, Nephrolithiasis · University of California, Los Angeles | Phase 1 / Phase 2 | Not yet recruiting | Feb 12, 2026 |
| Fecal Molecular Susceptibility-guided Hp First-line TherapyHELICOBACTER PYLORI INFECTIONS · Shanghai Zhongshan Hospital | Phase 4 | Not yet recruiting | Feb 12, 2026 |
| Urine Alkalinization for UTI in Women: RCTUTI - Urinary Tract Infection · Assiut University | Not applicable | Not yet recruiting | Oct 2, 2025 |
| Aug 30, 1985 | Urocit-KNDA 19071 · New dosage form | Mission Pharma | 9 | Marketed |
| Oct 13, 1988 | Potassium CitrateNDA 19647 · New dosage form | Ut Sw Medctr | 0 | Discontinued |
| Jun 8, 2006 | Potassium CitrateANDA 77440 | Rising | 1 | Marketed |
| Aug 6, 2014 | Potassium CitrateANDA 203546 | Zydus Pharms | 0 | Marketed |
| Sep 11, 2017 | Potassium CitrateANDA 206813 | Strides Pharma | 3 | Marketed |
| Mar 5, 2018 | Potassium CitrateANDA 209758 | Teva Pharms USA Inc | 0 | Marketed |
| Jan 14, 2020 | Potassium CitrateANDA 212779 | Ani Pharms | 1 | Marketed |
| Jun 29, 2020 | Potassium CitrateANDA 212799 | Bionpharma | 1 | Marketed |
| Feb 5, 2021 | Potassium CitrateANDA 214420 | Ascent Pharms Inc | 1 | Marketed |
| Feb 19, 2021 | Potassium CitrateANDA 214426 | Adaptis | 1 | Marketed |
| Feb 6, 2024 | Potassium CitrateANDA 213986 | Torrent | 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
Zydus Pharms
Strides Pharma