ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - Generic Drug Details

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

Albuterol sulfate; ipratropium bromide is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim, Apotex Inc, Cipla, Fosun Pharma, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, Watson Labs Teva, and Norvium Bioscience, and is included in twelve NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate; ipratropium bromide has one hundred and eighteen patent family members in thirty-six countries.

Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

International Patents:	118
US Patents:	6
Tradenames:	4
Applicants:	11
NDAs:	12
Finished Product Suppliers / Packagers:	15
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
DailyMed Link:	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE at DailyMed

Recent Clinical Trials for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

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

Sponsor	Phase
James J. Peters Veterans Affairs Medical Center	Phase 2
University of Texas Southwestern Medical Center	Phase 4
Dey	Phase 3

See all ALBUTEROL SULFATE; IPRATROPIUM BROMIDE clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMBIVENT RESPIMAT	Inhalation Aerosol	albuterol sulfate; ipratropium bromide	100 mcg/20 mcg per actuation	021747	1	2023-03-30

US Patents and Regulatory Information for ALBUTEROL SULFATE; 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
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva Pharms	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	076724-001	Dec 31, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	DUONEB	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	020950-001	Mar 21, 2001		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 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	COMBIVENT	albuterol sulfate; ipratropium bromide	AEROSOL, METERED;INHALATION	020291-001	Oct 24, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

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Country	Patent Number	Title	Estimated Expiration
Canada	2651190	PULVERISATEUR ET PROCEDE DE PULVERISATION D'UN FLUIDE (ATOMIZER AND METHOD OF ATOMIZING FLUID)	⤷ Sign Up
Ukraine	85865	ПРИСТРІЙ ДЛЯ КРІПЛЕННЯ СТРУМИННОЇ ДЕТАЛІ;устройство для крепления струйной детали (Device for fastening of fluidic component)	⤷ Sign Up
Brazil	0313816	Dispositivo de bloqueio para um mecanismo tensor de bloqueio com saìda ativada à mola	⤷ Sign Up
Japan	4411209		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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