Details for New Drug Application (NDA): 021395

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NDA 021395 describes SPIRIVA, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from two suppliers. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SPIRIVA profile page.

The generic ingredient in SPIRIVA 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 021395

Tradename:	SPIRIVA
Applicant:	Boehringer Ingelheim
Ingredient:	tiotropium bromide
Patents:	3

Pharmacology for NDA: 021395

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 021395

Bronchodilator Agents
Cholinergic Antagonists
Parasympatholytics

Suppliers and Packaging for NDA: 021395

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0075	0597-0075-41	3 BLISTER PACK in 1 CARTON (0597-0075-41) / 10 CAPSULE in 1 BLISTER PACK
SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0075	0597-0075-47	9 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	EQ 0.018MG BASE/INH
Approval Date:	Jan 30, 2004	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 12, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Jul 19, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Apr 19, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021395

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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