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Last Updated: June 14, 2024

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 ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 021395
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:RXDosage:POWDER;INHALATIONStrengthEQ 0.018MG BASE/INH
Approval Date:Jan 30, 2004TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 12, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Jul 19, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Apr 19, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021395

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
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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