Tools / Drug approvals and letters / Drugs Valsartan Treats hypertension. Sold as Diovan, Prexxartan. Every FDA application for this active ingredient: 3 branded and 24 generic.
As of Nov 14, 2026, FDA lists 27 applications for Valsartan (sold as Diovan, Prexxartan), first approved Dec 23, 1996, with 6 new uses approved and 0 published complete response letters.
First approved : Dec 23, 1996 Applications : 27 New uses approved : 6 Complete response letters : 0 Medicare spending, 2025 : $164M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Valsartan Part D $146M +14% 1,382,172 Diovan Part D $18.4M -11% 5,251
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change VALSARTAN 160 MG TABLET: $0.106 per unit Generic · -26% in a year VALSARTAN 320 MG TABLET: $0.170 per unit Generic · -13% in a year VALSARTAN 40 MG TABLET: $0.100 per unit Generic · -16% in a year VALSARTAN 80 MG TABLET: $0.081 per unit Generic · -36% in a year DIOVAN 160 MG TABLET: $10.04 per unit Brand · +2% in a year DIOVAN 320 MG TABLET: $12.69 per unit Brand · +3% in a year DIOVAN 40 MG TABLET: $7.82 per unit Brand · +3% in a year DIOVAN 80 MG TABLET: $9.33 per unit Brand · +3% in a year Diovan Drugs with a new additional pediatric dosage. · Novartis Pharma K.K. · Aug 24, 2012
Shortages FDA's drug shortage list, as of Nov 13, 2026 Shortage Status First posted Updated Valsartan Tablet To Be Discontinued Nov 19, 2025 Nov 19, 2025
Clinical Trials 59 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Blood Pressure Control and Safety of Ex-one or Ex-one Plus in Essential Hypertension Essential Hypertension · HK inno.N Corporation — Recruiting Nov 12, 2026 Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension Atrial Fibrillation (Persistent), Catheter Ablation · Ruijin Hospital Phase 4 Not yet recruiting Nov 2, 2026 Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure · Sunway University — Not yet recruiting Oct 30, 2026 Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients Hypertension, Left Ventricular Diastolic Dysfunction · University of Health Sciences Lahore Not applicable Not yet recruiting Oct 2, 2026 [11C]PS13 PET Imaging of Neuroinflammation in Heart Failure With Reduced Ejection Fraction Heart Failure With Reduced Ejection Fraction, Cognitive Impairment, Mild · Stony Brook University Phase 1 Not yet recruiting Oct 2, 2026 VITAL: Real-World Evaluation of Amlodipine/Valsartan. Hypertension, Cardiovascular Diseases (CVD) · VIVA PHARM LLP — Active, not recruiting Sep 29, 2026 Angiotensin Receptor Blocker After TAVR in Severe Aortic Stenosis With Left Ventricular Hypertrophy (ARBITAR) Transcatheter Aortic Valve Replacement (TAVR), Left Ventricular Hypertrophy · Seoul National University Hospital Phase 4 Not yet recruiting Jul 29, 2026 STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure Heart Failure With Reduced Ejection Fraction, Heart Failure · Kyungsub Song Phase 4 Recruiting Jun 5, 2026
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Dec 23, 1996 Diovan NDA 20665 · New molecular entity 25 Discontinued Jul 18, 2001 Diovan NDA 21283 · New dosage form 29 Marketed Jun 26, 2014 Valsartan ANDA 77492 5 Marketed Jan 5, 2015 Valsartan ANDA 90642 2 Discontinued Jan 5, 2015 Valsartan ANDA 90866 3 Marketed Jan 5, 2015 Valsartan ANDA 91367 3 Marketed Jan 5, 2015 Valsartan ANDA 201677 3 Discontinued Jan 5, 2015 Valsartan ANDA 202223 7 Marketed Jan 5, 2015 Valsartan ANDA 202728 4 Discontinued Jan 5, 2015 Valsartan ANDA 203311 5 Marketed Jan 5, 2015 Valsartan ANDA 203536 4 Marketed Jun 9, 2015 Valsartan ANDA 204821 5 Marketed Jan 4, 2016 Valsartan ANDA 77530 0 Discontinued Jan 11, 2016 Valsartan ANDA 204011 5 Marketed Sep 16, 2016 Valsartan ANDA 202696 4 Marketed Dec 19, 2017 Prexxartan NDA 209139 · New dosage form 1 Marketed Apr 9, 2018 Valsartan ANDA 205347 1 Marketed May 4, 2018 Valsartan ANDA 209261 3 Discontinued Mar 12, 2019 Valsartan ANDA 205536 1 Marketed Oct 5, 2021 Valsartan ANDA 201618 0 Marketed Oct 27, 2021 Valsartan ANDA 204038 1 Marketed Nov 2, 2021 Valsartan ANDA 214102 0 Marketed Jul 22, 2024 Valsartan ANDA 218991 0 Marketed Aug 5, 2024 Valsartan ANDA 218169 0 Discontinued Jun 5, 2025 Valsartan ANDA 216460 0 Marketed Apr 21, 2026 Valsartan ANDA 218897 0 Marketed Aug 11, 2026 Valsartan ANDA 205357 0 Marketed
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
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