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Last Updated: April 24, 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 021936-001 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 tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Lupin TIOTROPIUM BROMIDE tiotropium bromide POWDER;INHALATION 211287-001 Jun 20, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 021936-002 Sep 15, 2015 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ⤷  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
Canada 2552535 DISPOSITIF POUR FIXER UN COMPOSANT FLUIDIQUE (DEVICE FOR HOLDING A FLUIDIC COMPONENT) ⤷  Try a Trial
China 1646095 Inhalation kit comprisung inhalable powder of tiotropium ⤷  Try a Trial
South Korea 20060032162 MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION ⤷  Try a Trial
South Korea 101017850 ⤷  Try a Trial
Brazil PI0412043 bocal de alta pressão microestruturado com função de filtro embutida ⤷  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 05C0039 France ⤷  Try a Trial PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: 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
0418716 300084 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 C300084 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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