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Last Updated: March 19, 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
Oman Medical Speciality BoardPhase 4
Hat Yai Medical Education CenterPhase 3
The First Affiliated Hospital of Guangzhou Medical UniversityN/A

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
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
Nephron IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 075562-001 Sep 27, 2001 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 074755-001 Jan 10, 1997 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
Luoxin Aurovitas IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 206543-001 Oct 27, 2016 AN RX No 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 SPRAY, METERED;NASAL 020393-001 Oct 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
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 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

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