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Last Updated: September 22, 2021

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Tiotropium bromide - Generic Drug Details

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What are the generic drug 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 eight drug master file entries for tiotropium bromide. Two 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
Nemours Children's ClinicPhase 2
Rho, Inc.Phase 2
Nephron Pharmaceuticals CorporationPhase 2

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 NDA Submissiondate
SPIRIVA POWDER;INHALATION tiotropium bromide 021395 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 ⤷  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

Supplementary Protection Certificates for tiotropium bromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0418716 SPC/GB02/036 United Kingdom ⤷  Free Forever 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 C300084 Netherlands ⤷  Free Forever Trial PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 05C0039 France ⤷  Free Forever Trial PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Colorcon
Moodys
Merck
Baxter

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