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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Citi
Mallinckrodt
Fish and Richardson
Colorcon
Julphar
Queensland Health
Cantor Fitzgerald
Johnson and Johnson

Generated: June 18, 2018

DrugPatentWatch Database Preview

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 twenty-one patents protecting this drug. 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:10
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 N 0597-0075-41
SPIRIVA tiotropium bromide POWDER;INHALATION 021395 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0075 N 0597-0075-47

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 0.018MG BASE/INH
Approval Date:Jan 30, 2004TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 24, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Mar 24, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jul 22, 2022Product Flag?Substance Flag?Delist Request?Y

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 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Baxter
Daiichi Sankyo
Colorcon
Cantor Fitzgerald
Federal Trade Commission
Cerilliant
McKinsey
Moodys

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