Viewing data from:

ISORDIL

NDA

ISOSORBIDE DINITRATE | N012940 | BIOVAIL LABORATORIES INC

3 strengths0 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and hydralazine hydrochloride), a fixed-dose combination approved in 2005 for heart failure treat	Other	2008-06-24	Withdrawn	NitroMed, Inc. (Fox Kiser)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

21 trials from ClinicalTrials.gov, 1 active, 15 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers NCT02789033	Phase 3	Completed	University of Guadalajara	68	2015-06 → 2015-08
DANHEART (H-HeFT and Met-HeFT)NCT03514108	Phase 4	Completed	Henrik Wiggers	1,100	2018-03-01 → 2025-12-31
A Comparison of Various Combinations of BiDil Capsules and BiDil Tablets in Healthy Human Volunteers NCT01587313	Phase 1	Completed	Arbor Pharmaceuticals, Inc.	36	2012-04 → 2012-05
Asymptomatic Cardiac Ischemia Pilot (ACIP) Study NCT00000478	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1990-11 → 1997-06
Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.NCT02258620	N/A	Completed	Brugmann University Hospital	442	2013-06 → 2014-09
Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects NCT00810381	N/A	Completed	Medical University of Vienna	14	1999-01 → 1999-06
Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets NCT02522208	Phase 1	Completed	Arbor Pharmaceuticals, Inc.	12	2015-09 → 2016-04
Nitrate Effect on Exercise Capacitance NCT04297241	Phase 2	Completed	Children's Hospital Medical Center, Cincinnati	20	2019-12-12 → 2021-05-03
Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction NCT01516346	Phase 2	Completed	Corporal Michael J. Crescenz VA Medical Center	44	2012-01 → 2017-08-18

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

API Supply Chain3 active DMFs8 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

DOTTIKON EXCLUSIVE SYNTHESIS AGISOSORBIDE DINITRATE, DILUTED

DMF 26631976

DIPHARMA FRANCIS SRLISOSORBIDE DINITRATE (ISDN)

DMF 37251980

EIRCHEM PHARMA SERVICES LTDISOSORBIDE DINITRATE DILUTED

DMF 92281991

NYSCO LABS INCInactiveISOSORBIDE DINITRATE TIMED RELEASE PELLETS

DMF 10211967

NAPP-LEMKE CHEMS INCInactiveISOSORBIDE DINITRATE

DMF 17911971

EUTICALS LTDInactiveISOSORBIDE DINITRATE BULK

DMF 18551972

PALMER RESEARCH LABORATORIESInactiveISOSORBIDE DINITRATE TRITURATE

DMF 18571972

BOFORS INDSInactiveISOSORBIDE DINITRATE

DMF 22381974

SANOL SCHWARZInactiveISOSORBIDE DINITRATE TRANSDERMAL SUSPENSION

DMF 42241981

LYPHOMED INCInactiveISOSORBIDE DINITRATE INJECTION (50ML AND 100ML)

DMF 57611985

INDUSTRIAS QUIMICAS TAUBATE SAInactiveISOSORBIDE DINITRATE

DMF 77071988

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 16, 2001	SUPPL -44	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#003 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;SUBLINGUAL | Approved: Jul 29, 1988

No patent or exclusivity listings for this strength.

#004 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Jul 29, 1988

#005 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Jul 29, 1988