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Last Updated: March 28, 2024

SPIRIVA RESPIMAT Drug Patent Profile


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When do Spiriva Respimat patents expire, and when can generic versions of Spiriva Respimat launch?

Spiriva Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighteen patent family members in thirty-six countries.

The generic ingredient in SPIRIVA RESPIMAT 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Spiriva Respimat

A generic version of SPIRIVA RESPIMAT was approved as tiotropium bromide by LUPIN on June 20th, 2023.

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Drug patent expirations by year for SPIRIVA RESPIMAT
Drug Prices for SPIRIVA RESPIMAT

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Recent Clinical Trials for SPIRIVA RESPIMAT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of SaskatchewanPhase 4
Nemours Children's ClinicPhase 2
Nephron Pharmaceuticals CorporationPhase 2

See all SPIRIVA RESPIMAT clinical trials

Pharmacology for SPIRIVA RESPIMAT
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Paragraph IV (Patent) Challenges for SPIRIVA RESPIMAT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SPIRIVA RESPIMAT Inhalation Aerosol tiotropium bromide 2.5 mcg per actuation 021936 1 2023-03-07

US Patents and Regulatory Information for SPIRIVA RESPIMAT

SPIRIVA RESPIMAT is protected by six US patents.

Patents protecting SPIRIVA RESPIMAT

Piston-pumping system having o-ring seal properties
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Device for clamping a fluidic component
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Microstructured high pressure nozzle with built-in filter function
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Device for clamping a fluidic component
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SPIRIVA RESPIMAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SPIRIVA RESPIMAT

See the table below for patents covering SPIRIVA RESPIMAT around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1772175 ⤷  Try a Trial
European Patent Office 1641569 AJUTAGE HAUTE PRESSION MICROSTRUCTURE COMPORTANT UNE FONCTION DE FILTRAGE INTEGREE (MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION) ⤷  Try a Trial
Poland 357832 ⤷  Try a Trial
Israel 124343 LOCKING MECHANISM FOR A SPRING-ACTUATED DEVICE ⤷  Try a Trial
Japan H08501979 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SPIRIVA RESPIMAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0418716 C300084 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 05C0039 France ⤷  Try a Trial PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
0418716 300084 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 0290010-8 Sweden ⤷  Try a Trial PRODUCT NAME: TIOTROPIUM, 3BETA-(DI(2-TIENYL)HYDROXIACETOXI)-6BETA,7BETA-EPO XI-8METYL-1ALFAH,5ALFAH-TROPANIUM, ELLER ETT SALT DAERAV; NAT. REGISRTATION NO/DATE: 18094 20020503; FIRST REGISTRATION: NL RVG 26 191 20011009
0418716 SPC/GB02/036 United Kingdom ⤷  Try a Trial PRODUCT NAME: SCOPINE DI-(2-THIENYL)GLYCOLATE IN THE FORM OF THE QUATERNARY SALTS - ESPECIALLY SALTS OF TIOTROPIUM - PREFERRED TIOTROPIUMBROMIDE AND TIOTROPIUMBROMIDE MONOHYDRATE; REGISTERED: NL RVG26191 20011009; UK PL14598/0062 20020514
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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