Viewing data from:

BAXFENDY

NDA

BAXDROSTAT | N219878 | ASTRAZENECA AB

2 strengths1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

Today

9353081

Feb. 4, 2033

NCE

May. 15, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

9 trials from ClinicalTrials.gov — 4 recruiting, 3 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.NCT06268873	Phase 3	Active	AstraZeneca	2,554	2024-03-29 → 2028-02-24
A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.NCT07222917	Phase 2	Active	AstraZeneca	222	2025-12-05 → 2026-12-10
Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.NCT07007793	Phase 3	Active	AstraZeneca	212	2025-08-07 → 2028-08-14
Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism NCT07800858	N/A	Not Yet Recruiting	Queen Mary University of London	30	2026-09-15 → 2028-05-31
A Phase IIIb Study to Investigate the Effect of Baxdrostat in Chinese Participants With Uncontrolled Hypertension.NCT07686120	Phase 3	Recruiting	AstraZeneca	286	2026-09-17 → 2028-02-09
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure NCT06742723	Phase 3	Recruiting	AstraZeneca	5,000	2025-03-03 → 2029-12-18
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin NCT06677060	Phase 3	Recruiting	AstraZeneca	11,300	2025-03-14 → 2029-12-17
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension NCT06034743	Phase 3	Completed	AstraZeneca	796	2023-11-22 → 2025-10-10
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension NCT06168409	Phase 3	Completed	AstraZeneca	218	2024-03-01 → 2025-08-17

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$28.96

per ea

Lowest NADAC/Unit

$28.84

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00310600130BAXFENDY 1 MG TABLET	$28.96	EA	Brand	—	2026-10-21
00310600230BAXFENDY 2 MG TABLET	$28.84	EA	Brand	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 15, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG

RLD

1 patent1 exclusivity▴

TABLET;ORAL | Approved: May 15, 2026

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9353081	Feb 4, 2033	—	Yes	Yes	—	—

Exclusivities (1)

Code	Date	Status
NCE	May 15, 2031	Active

#002 — 2MG

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: May 15, 2026