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Tiotropium bromide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for tiotropium bromide?

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.

This ingredient has seven hundred and sixty patent family members in sixty-one countries.

There are eight drug master file entries for tiotropium bromide. Four suppliers are listed for this compound.

Summary for Generic Name: tiotropium bromide

Tradenames:2
Patents:33
Applicants:1
NDAs:2
Drug Master File Entries: see list8
Suppliers / Packagers: see list4
Bulk Api Vendors: see list54
Clinical Trials: see list133
Patent Applications: see list2,375
Drug Prices:see low prices
DailyMed Link:tiotropium bromide at DailyMed

Pharmacology for Ingredient: tiotropium bromide

Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
SPIRIVA
tiotropium bromide
POWDER;INHALATION021395-001Jan 30, 2004RXYesYes6,777,423*PED► SubscribeY► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-002Sep 15, 2015RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
SPIRIVA
tiotropium bromide
POWDER;INHALATION021395-001Jan 30, 2004RXYesYes7,309,707*PED► SubscribeY► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-002Sep 15, 2015RXYesNo9,027,967*PED► SubscribeY► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 2014RXYesYes8,733,341*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tiotropium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 20146,176,242► Subscribe
Boehringer Ingelheim
SPIRIVA
tiotropium bromide
POWDER;INHALATION021395-001Jan 30, 20045,478,578► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-002Sep 15, 20157,104,470► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-002Sep 15, 20157,246,615► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-002Sep 15, 20156,149,054► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
6,402,055 Device for producing high pressure in a fluid in miniature► Subscribe
7,645,383Microstructured filter► Subscribe
6,503,440 Process for making a container with a pressure equalization opening and containers produced accordingly► Subscribe
6,503,362 Atomizing nozzle an filter and spray generating device► Subscribe
5,547,094 Method for producing atomizing nozzle assemblies► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: tiotropium bromide

Country Document Number Estimated Expiration
China1269470► Subscribe
Germany69333938► Subscribe
MexicoPA02005666► Subscribe
China1093006► Subscribe
Japan3764422► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TIOTROPIUM BROMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/036United Kingdom► SubscribePRODUCT 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
90010-8Sweden► SubscribePRODUCT 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
0084Netherlands► SubscribePRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
C0039France► SubscribePRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
00084Netherlands► SubscribePRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
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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 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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