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Last Updated: March 28, 2024

TIOTROPIUM BROMIDE - Generic Drug Details


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What are the generic sources for tiotropium bromide and what is the scope of freedom to operate?

Tiotropium bromide is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Lupin, and is included in three NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tiotropium bromide has one hundred and seventy-eight patent family members in thirty-seven countries.

There are seven drug master file entries for tiotropium bromide. Three suppliers are listed for this compound.

Summary for TIOTROPIUM BROMIDE
Recent Clinical Trials for TIOTROPIUM BROMIDE

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

SponsorPhase
Boehringer IngelheimN/A
Guangzhou Institute of Respiratory DiseaseN/A
University of SaskatchewanPhase 4

See all TIOTROPIUM BROMIDE clinical trials

Pharmacology for TIOTROPIUM BROMIDE
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for TIOTROPIUM BROMIDE
Paragraph IV (Patent) Challenges for TIOTROPIUM BROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SPIRIVA RESPIMAT Inhalation Aerosol tiotropium bromide 2.5 mcg per actuation 021936 1 2023-03-07
SPIRIVA Inhalation Powder Capsules tiotropium bromide 18 mcg 021395 1 2018-05-11

US Patents and Regulatory Information for TIOTROPIUM BROMIDE

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 tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 AB 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 TIOTROPIUM BROMIDE

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 021936-002 Sep 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TIOTROPIUM BROMIDE

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 008027 МИКРОСТРУКТУРИРОВАННАЯ СОПЛОВАЯ ГОЛОВКА ВЫСОКОГО ДАВЛЕНИЯ С ИНТЕГРИРОВАННОЙ ФИЛЬТРУЮЩЕЙ ФУНКЦИЕЙ (MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION) ⤷  Try a Trial
Hong Kong 1084909 Blocking device for a sprung lock with a spring operation ⤷  Try a Trial
Japan 5649980 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TIOTROPIUM BROMIDE

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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.