Details for New Drug Application (NDA): 021936

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NDA 021936 describes SPIRIVA RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the SPIRIVA RESPIMAT profile page.

The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.

Summary for 021936

Tradename:	SPIRIVA RESPIMAT
Applicant:	Boehringer Ingelheim
Ingredient:	tiotropium bromide
Patents:	5

Pharmacology for NDA: 021936

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 021936

Bronchodilator Agents
Cholinergic Antagonists
Parasympatholytics

Suppliers and Packaging for NDA: 021936

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0100	0597-0100-28	1 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE
SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0100	0597-0100-51	1 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 SPRAY, METERED in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;INHALATION			Strength	EQ 0.0025MG BASE/INH
Approval Date:	Sep 24, 2014	TE:		RLD:	Yes
Patent:	7,284,474*PED	Patent Expiration:	Feb 26, 2025	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	7,396,341*PED	Patent Expiration:	Apr 10, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	7,837,235*PED	Patent Expiration:	Sep 13, 2028	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021936

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014	6,176,442*PED	⤷ Get Started Free
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014	6,149,054*PED	⤷ Get Started Free
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015	6,977,042*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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