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ATROVENT

NDA

IPRATROPIUM BROMIDE | N020394 | BOEHRINGER INGELHEIM 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 Lachman Consulting Services, Inc FDA-2020-P-2174 · 6 docket documents Lachman Consulting Services, Inc. filed this citizen petition requesting that the FDA determine whether Atrovent (ipratropium bromide) Nasal Spray at strengths 0.021MG/SPRAY and 0.042MG/SPRAY, approved under NDA Numbers N020393 and N020394 and held by Boehringer Ingelheim Pharmaceuticals Inc., were	505(q)	2020-11-06	Denied	Lachman Consulting Services, Inc

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

Clinical Trials

70 trials from ClinicalTrials.gov, 58 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT03064113	Phase 2	Completed	Mylan Inc.	32	2011-05 → 2011-10
Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia NCT00904436	N/A	Completed	US Department of Veterans Affairs	20	1999-12 → 2001-01
Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)NCT00202176	Phase 4	Completed	Queen's University	32	2005-07 → 2008-12
Sensitivity of New Exercise Tests in Chronic Obstructive Pulmonary Disease (COPD)NCT00807534	N/A	Completed	Laval University	44	2008-10 → 2010-06
Efficacy and Safety of Tiotropium and Atrovent in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT02172469	Phase 3	Completed	Boehringer Ingelheim	215	2001-05
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment NCT02172781	Phase 1	Completed	Boehringer Ingelheim	36	2001-01
Comparison of Tiotropium and Ipratropium in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With COPD NCT00274040	Phase 3	Completed	Boehringer Ingelheim	141	2002-07 → 2003-03
Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma NCT04167280	Phase 4	Completed	University of Saskatchewan	12	2019-11-05 → 2020-03-13
Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus NCT02872597	Phase 1	Completed	University Hospitals Cleveland Medical Center	30	2016-09-05 → 2018-08-16
A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20g, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)NCT00239434	Phase 3	Completed	Boehringer Ingelheim	200	2003-06 → 2004-03

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

API Supply Chain7 active DMFs2 inactive

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

OLON SPAIPRATROPIUM BROMIDE

DMF 89731991

LUSOCHIMICA SPAIPRATROPIUM BROMIDE

DMF 89791991

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGIPRATROPIUM BROMIDE MONOHYDRATE

DMF 142591999

NEULAND LABORATORIES LTDIPRATROPIUM BROMIDE USP

DMF 151302000

AARTI PHARMALABS LTDIPRATROPIUM BROMIDE

DMF 211792007

AMPHASTAR NANJING PHARMACEUTICALS INCIPRATROPIUM BROMIDE USP

DMF 310362017

SCL LIFESCIENCES LTDIPRATROPIUM BROMIDE USP

DMF 379412025

DERIVADOS QUIMICOS SA FINE CHEMICALSInactiveIPRATROPIUM BROMIDE

DMF 231352009

CIPLA LTDInactiveIPRATROPIUM BROMIDE USP

DMF 298432015

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 24, 2011	SUPPL -12	View Letter (PDF)
Oct 21, 2008	SUPPL -8	View Letter (PDF)
May 30, 2003	SUPPL -5	View Letter (PDF)
Nov 9, 1998	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Oct 20, 1995

No patent or exclusivity listings for this strength.