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Last Updated: March 28, 2024

Ipratropium bromide - Generic Drug Details


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What are the generic drug sources for ipratropium bromide and what is the scope of patent protection?

Ipratropium bromide is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Mylan Speciality Lp, Nephron, 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. Nineteen suppliers are listed for this compound.

Drug Sales Revenue Trends for ipratropium bromide

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Recent Clinical Trials for ipratropium bromide

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SponsorPhase
Hat Yai Medical Education CenterPhase 3
The First Affiliated Hospital of Guangzhou Medical UniversityN/A
Oman Medical Speciality BoardPhase 4

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
Bausch IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076103-001 Mar 31, 2003 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076598-001 Nov 5, 2003 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 215105-001 Aug 16, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Usa IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 075552-001 Mar 31, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 075835-001 Oct 15, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076156-001 Apr 18, 2003 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT ipratropium bromide SOLUTION;INHALATION 020228-001 Sep 29, 1993 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ipratropium bromide AEROSOL, METERED;INHALATION 019085-001 Dec 29, 1986 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527-001 Nov 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT ipratropium bromide SPRAY, METERED;NASAL 020394-001 Oct 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT ipratropium bromide SPRAY, METERED;NASAL 020393-001 Oct 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527-001 Nov 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527-001 Nov 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527-001 Nov 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ipratropium bromide

Country Patent Number Title Estimated Expiration
European Patent Office 2203205 INHALATEUR (INHALER DEVICE) ⤷  Try a Trial
Germany 102007045438 Inhalier-Gerät ⤷  Try a Trial
Denmark 2203205 ⤷  Try a Trial
Spain 2539285 ⤷  Try a Trial
Canada 2700201 INHALATEUR (INHALER DEVICE) ⤷  Try a Trial
Hungary E025069 ⤷  Try a Trial
Japan 2010538780 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.