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Last Updated: November 2, 2024

IPRATROPIUM BROMIDE - Generic Drug Details


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What are the generic sources for ipratropium bromide and what is the scope of freedom to operate?

Ipratropium bromide is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Nephron, Norvium Bioscience, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, and Hikma, and is included in twenty-eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Ipratropium bromide has ten patent family members in nine countries.

There are eight drug master file entries for ipratropium bromide. Eighteen suppliers are listed for this compound.

Summary for IPRATROPIUM BROMIDE
International Patents:10
US Patents:1
Tradenames:3
Applicants:17
NDAs:28
Drug Master File Entries: 8
Finished Product Suppliers / Packagers: 18
Raw Ingredient (Bulk) Api Vendors: 69
Clinical Trials: 85
Patent Applications: 7,141
What excipients (inactive ingredients) are in IPRATROPIUM BROMIDE?IPRATROPIUM BROMIDE excipients list
DailyMed Link:IPRATROPIUM BROMIDE at DailyMed
Drug Sales Revenue Trends for IPRATROPIUM BROMIDE

See drug sales revenues for IPRATROPIUM BROMIDE

Recent Clinical Trials for IPRATROPIUM BROMIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wake Forest University Health SciencesPhase 2
University of UtahPhase 2
Oregon Health and Science UniversityPhase 2

See all IPRATROPIUM BROMIDE clinical trials

Pharmacology for IPRATROPIUM BROMIDE
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for IPRATROPIUM BROMIDE
Paragraph IV (Patent) Challenges for IPRATROPIUM BROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ATROVENT HFA Inhalation Aerosol ipratropium bromide 0.21 mg/Inh 021527 1 2023-12-29

US Patents and Regulatory Information for IPRATROPIUM BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 075313-001 Feb 7, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zennova IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 075507-001 Jan 19, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Usa IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 075552-001 Mar 31, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nephron IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 075562-001 Sep 27, 2001 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for IPRATROPIUM BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527-001 Nov 27, 2004 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim ATROVENT ipratropium bromide AEROSOL, METERED;INHALATION 019085-001 Dec 29, 1986 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim ATROVENT ipratropium bromide SPRAY, METERED;NASAL 020393-001 Oct 20, 1995 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim ATROVENT ipratropium bromide SPRAY, METERED;NASAL 020394-001 Oct 20, 1995 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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