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Last Updated: October 26, 2021

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 sixteen 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. Two 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:9
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 021395
Generic Entry Date for 021395*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
Paragraph IV (Patent) Challenges for 021395
Tradename Dosage Ingredient NDA Submissiondate
SPIRIVA POWDER;INHALATION tiotropium bromide 021395 2018-05-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 0.018MG BASE/INH
Approval Date:Jan 30, 2004TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Mar 24, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Free Forever TrialPatent Expiration:Mar 24, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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