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

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Recent Clinical Trials for IPRATROPIUM BROMIDE

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

Sponsor	Phase
University at Buffalo	Phase 2
Wake Forest University Health Sciences	Phase 2
University of Utah	Phase 2

See all IPRATROPIUM BROMIDE clinical trials

Pharmacology for IPRATROPIUM BROMIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for IPRATROPIUM BROMIDE

Bronchodilator Agents
Cholinergic Antagonists

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ritedose Corp	IPRATROPIUM BROMIDE	ipratropium bromide	SOLUTION;INHALATION	075693-001	Jan 26, 2001	AN	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	076598-001	Nov 5, 2003	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	076664-001	Nov 5, 2003	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	ATROVENT	ipratropium bromide	SPRAY, METERED;NASAL	020393-001	Oct 20, 1995		DISCN	Yes	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

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

International Patents for IPRATROPIUM BROMIDE

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Country	Patent Number	Title	Estimated Expiration
Japan	5436430		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2009037085		⤷ Sign Up
Hungary	E025069		⤷ Sign Up
European Patent Office	2203205	INHALATEUR (INHALER DEVICE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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