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  2. ›drugs
  3. ›SACUBITRIL AND VALSARTAN
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SACUBITRIL AND VALSARTAN

Marketedupdated 3mo ago
by Somerset Therapeutics LLC
Approved
community read0 votes

🐶 often sniffed alongside

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all catalysts(1)

approval · 1
Jan 20, 2026
approval
7mo ago
SACUBITRIL AND VALSARTAN (SACUBITRIL) — FDA approval
SACUBITRIL AND VALSARTAN
→

Trials studying SACUBITRIL AND VALSARTAN

  • phase2A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failureterminatedn=136
  • phase3Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202Arecruitingn=324
  • phase4Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCCcompletedn=918
  • phase3A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Studycompletedn=8
  • phase3Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HFcompletedn=216
  • phase1Bioequivalence Study to Compare Sacubitril and Valsartan Tablets (97mg/103mg) Versus Entresto® (Sacubitril and Valsartan) Tablets (97 mg/103 mg)completedn=48
  • phase3Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)completedn=467
  • phase2Prevention of Cardiac Dysfunction During Breast Cancer Therapycompletedn=138
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 8, 2026
89 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (6)

  • Feb 2, 2037formulationUS 10722471
  • Feb 2, 2037formulationUS 10722471
  • May 27, 2027compositionUS 8877938289d
  • May 27, 2027compositionUS 8877938289d
  • Nov 8, 2026method-of-use (U-1723)US 938813489d
  • Nov 8, 2026method-of-use (U-1723)US 938813489d

News(0)

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brand
SACUBITRIL AND VALSARTAN
generic
SACUBITRIL
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 1h ago
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