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SPIRIVA RESPIMAT Drug Profile
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Which patents cover Spiriva Respimat, and what generic alternatives are available?
Spiriva Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are eight patents protecting this drug.
This drug has two hundred and twenty patent family members in forty-five countries.
The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
US ANDA Litigation and Generic Entry Outlook for Spiriva Respimat
Indicators of Generic Entry
Summary for SPIRIVA RESPIMAT
| International Patents: | 220 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 88 |
| Clinical Trials: | 24 |
| Patent Applications: | 2,893 |
| Drug Prices: | Drug price information for SPIRIVA RESPIMAT |
| DailyMed Link: | SPIRIVA RESPIMAT at DailyMed |
Recent Clinical Trials for SPIRIVA RESPIMAT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai Zhongshan Hospital | N/A |
| Boehringer Ingelheim | Phase 4 |
| Università degli Studi di Ferrara | Phase 4 |
Pharmacology for SPIRIVA RESPIMAT
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
US Patents and Regulatory Information for SPIRIVA RESPIMAT
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 SPIRIVA RESPIMAT
| 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 | Start Trial | Start Trial |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | Start Trial | Start Trial |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | Start Trial | Start Trial |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | Start Trial | Start Trial |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPIRIVA RESPIMAT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4411209 | Start Trial |
| Norway | 921002 | Start Trial |
| Croatia | P960448 | Start Trial |
| Croatia | P980526 | Start Trial |
| Czech Republic | 295757 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SPIRIVA RESPIMAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0418716 | 0290010-8 | Sweden | Start Trial | 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 | SPC/GB02/036 | United Kingdom | Start 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 | 05C0039 | France | Start Trial | PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009 |
| 0418716 | C300084 | Netherlands | Start Trial | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
| 0418716 | 300084 | Netherlands | Start Trial | 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 |
