Viewing data from:

BIDIL

NDA

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE | N020727 | AZURITY PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from NitroMed, Inc. (Fox Kiser) FDA-2006-P-0444 · 6 docket documents NitroMed, Inc. filed this citizen petition under 21 CFR § 10.30 requesting that the FDA confirm it has not determined any drug to be therapeutically equivalent or AB-rated to BiDil (isosorbide dinitrate and hydralazine hydrochloride), a fixed-dose combination approved in 2005 for heart failure treat	Other	2008-06-24	Withdrawn	NitroMed, Inc. (Fox Kiser)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$4.35

per ea

Lowest NADAC/Unit

$0.7302

per ea

Brand NDCs

Generic NDCs

Avg Brand: $4.35

Avg Generic: $0.7302

83% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24338001009BIDIL 20 MG-37.5 MG TABLET	$4.35	EA	Brand	$0.7302	2026-02-18
52536000609ISOSORBIDE-HYDRALAZINE 20-37.5 MG TABLET	$0.7302	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (2 FSS, 1 Big4)

Lowest Price

$26.57

Highest Price

$291.49

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24338-0010-09BIDIL 37.5/20MG TAB	$291.49	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0010-09BIDIL 37.5/20MG TAB	$282.97	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
52536-0006-09HYDRALAZINE HCL 37.5MG/ISOSORBIDE DN 20MG	$26.57	FSS	Wilshire Pharmaceuticals, Inc.	06/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Bidil (2024)

Total Spending

$520K

Total Claims

923

Beneficiaries

301

Avg Cost/Unit

$4.17

Spending Trend

$1.6M(2020)→$13.9M(2021)→$8.8M(2022)→$1.6M(2023)→$520K(2024)

YoY Change:-2.4%

5yr CAGR:+2.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
May 19, 2021	SUPPL -12	View Letter (PDF)
Mar 14, 2019	SUPPL -10	View Letter (PDF)
Apr 3, 2015	SUPPL -5	View Letter (PDF)
Mar 29, 2013	SUPPL -4	View Letter (PDF)
Jun 24, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 37.5MG;20MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 23, 2005

No patent or exclusivity listings for this strength.