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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

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 seven 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. Two 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:7
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 021936
Generic Entry Date for 021936*:
Constraining patent/regulatory exclusivity:
Dosage:
SPRAY, METERED;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: 021936
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 021936
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:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.0025MG BASE/INH
Approval Date:Sep 24, 2014TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Feb 26, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Free Forever TrialPatent Expiration:Apr 10, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Free Forever TrialPatent Expiration:Sep 13, 2028Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021936

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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