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Last Updated: August 17, 2022

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 two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tiotropium bromide has four hundred and sixty-nine patent family members in fifty-three countries.

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

Summary for tiotropium bromide
Recent Clinical Trials for tiotropium bromide

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

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Pharmacology for tiotropium bromide
Drug ClassAnticholinergic
Mechanism of Action Cholinergic 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 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 tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

International Patents for tiotropium bromide

Country Patent Number Title Estimated Expiration
Israel 209401 See Plans and Pricing
Israel 163841 תהליך להכנת גביש בגודל מיקרוני, גביש בגודל מיקורני של טיאוטרופיום ברומיד ושימוש בו להכנת תכשיר רוקחות ותכשיר זה כאבקה לשאיפה (Process for preparing crystalline micronisate, crystalline tiotropium bromide micronisate and its use for preparing a pharmaceutical composition and such composition as inhalable powder) See Plans and Pricing
Hungary 0302373 See Plans and Pricing
Croatia P20080013 See Plans and Pricing
Israel 154919 PROCESS FOR PREPARING INHALABLE POWDERS AND INHALABLE POWDER OBTAINED BY SUCH PROCESS See Plans and Pricing
Japan 2009536051 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tiotropium bromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0418716 SPC/GB02/036 United Kingdom See Plans and Pricing 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 C300084 Netherlands See Plans and Pricing PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 0290010-8 Sweden See Plans and Pricing 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 05C0039 France See Plans and Pricing PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
0418716 300084 Netherlands See Plans and Pricing 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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