SPIRIVA RESPIMAT Drug Patent 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 six patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eighteen patent family members in thirty-six countries.
The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Spiriva Respimat
A generic version of SPIRIVA RESPIMAT was approved as tiotropium bromide by LUPIN on June 20th, 2023.
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Summary for SPIRIVA RESPIMAT
| International Patents: | 118 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 27 |
| Patent Applications: | 3,419 |
| Drug Prices: | Drug price information for SPIRIVA RESPIMAT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SPIRIVA RESPIMAT |
| What excipients (inactive ingredients) are in SPIRIVA RESPIMAT? | SPIRIVA RESPIMAT excipients list |
| DailyMed Link: | SPIRIVA RESPIMAT at DailyMed |
Recent Clinical Trials for SPIRIVA RESPIMAT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Saskatchewan | Phase 4 |
| Nemours Children's Clinic | Phase 2 |
| Nephron Pharmaceuticals Corporation | Phase 2 |
Pharmacology for SPIRIVA RESPIMAT
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Paragraph IV (Patent) Challenges for SPIRIVA RESPIMAT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SPIRIVA RESPIMAT | Inhalation Aerosol | tiotropium bromide | 2.5 mcg per actuation | 021936 | 1 | 2023-03-07 |
US Patents and Regulatory Information for SPIRIVA RESPIMAT
SPIRIVA RESPIMAT is protected by six US patents.
Patents protecting SPIRIVA RESPIMAT
Piston-pumping system having o-ring seal properties
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Device for clamping a fluidic component
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Microstructured high pressure nozzle with built-in filter function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Device for clamping a fluidic component
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPIRIVA RESPIMAT
See the table below for patents covering SPIRIVA RESPIMAT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 183810 | ⤷ Sign Up | |
| Germany | 10330370 | Mikrostrukturiertes Filter mit Anti-Verdunstungseinrichtung | ⤷ Sign Up |
| Germany | 19536903 | Vorrichtung zum Haltern eines fluidischen Bauteils | ⤷ Sign Up |
| Australia | 2004311644 | Device for holding a fluidic component | ⤷ Sign Up |
| Slovenia | 869825 | ⤷ Sign Up | |
| New Zealand | 320158 | Device for mounting a component exposed to a pressurized fluid | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPIRIVA RESPIMAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0418716 | 05C0039 | France | ⤷ Sign Up | PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009 |
| 0418716 | C300084 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
| 0418716 | 0290010-8 | Sweden | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | 300084 | Netherlands | ⤷ Sign Up | 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 |
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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 verification 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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