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Generated: July 24, 2017
What is the patent landscape for Spiriva, and what generic Spiriva alternatives are available?
Spiriva is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are thirty-two patents protecting this drug.| Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 3 |
| Bulk Api Vendors: see list | 58 |
| Clinical Trials: see list | 85 |
| Patent Applications: see list | 2,469 |
| Drug Prices: | see details |
| DailyMed Link: | SPIRIVA at DailyMed |
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
| 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 | ► 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 | 021936-001 | Sep 24, 2014 | 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 RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,585,959 | Process for preparing powder formulations | ► Subscribe | |||||||||||||||||||||||||||
| 5,610,163 | Esters of thienyl carboxylic acids and amino alcohols and their quaternization products | ► 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Costa Rica | 6937 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20020437 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 1326862 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20022414 | ► Subscribe | |||||||||||||||||||||||||||
| Colombia | 5611105 | ► 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 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 0084 | Netherlands | ► Subscribe | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 | ||||||||||||||||||||||||||
| C0039 | France | ► Subscribe | PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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