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Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
Harvard Business School
Fuji
Julphar
Merck
Cantor Fitzgerald
Cerilliant
Accenture
Teva

Generated: January 19, 2018

DrugPatentWatch Database Preview

Tiotropium bromide - Generic Drug Details

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What are the generic drug sources for tiotropium bromide and what is the scope of tiotropium bromide 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 thirty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tiotropium bromide has eight hundred and fifty-two patent family members in sixty-three countries.

There are eight drug master file entries for tiotropium bromide. Three suppliers are listed for this compound.
Summary for tiotropium bromide
Pharmacology for tiotropium bromide
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for tiotropium bromide

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 No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ➤ Subscribe ➤ Subscribe
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for tiotropium bromide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,497,373 Device for producing high pressure in a fluid in miniature ➤ Subscribe
6,585,959 Process for preparing powder formulations ➤ Subscribe
7,645,383 Microstructured filter ➤ Subscribe
7,451,884 Container provided with a pressure equalization opening ➤ Subscribe
6,007,676 Atomizing nozzle and filter and spray generating device ➤ Subscribe
6,503,440 Process for making a container with a pressure equalization opening and containers produced accordingly ➤ Subscribe
5,472,143 Atomising nozzle and filter and spray generation device ➤ Subscribe
6,503,362 Atomizing nozzle an filter and spray generating device ➤ Subscribe
6,918,547 Device for producing high pressure in a fluid in miniature ➤ Subscribe
6,402,055 Device for producing high pressure in a fluid in miniature ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for tiotropium bromide

Supplementary Protection Certificates for tiotropium bromide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90010-8 Sweden ➤ Subscribe 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
C0039 France ➤ Subscribe PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
0084 Netherlands ➤ Subscribe PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
C/GB02/036 United Kingdom ➤ Subscribe 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
00084 Netherlands ➤ Subscribe PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Accenture
US Army
Fuji
Merck
Novartis
Argus Health
Julphar
Chinese Patent Office

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 verifification 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.

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