SPIRIVA RESPIMAT Drug Patent Profile
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When do Spiriva Respimat patents expire, and when can generic versions of Spiriva Respimat launch?
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.
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: | 3,451 |
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 |
Rho, Inc. | Phase 2 |
Pharmacology for SPIRIVA RESPIMAT
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for SPIRIVA RESPIMAT
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Device for clamping a fluidic component
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Microstructured high pressure nozzle with built-in filter function
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Device for clamping a fluidic component
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
China | 1299662 | ⤷ Try a Trial | |
Slovakia | 284636 | ⤷ Try a Trial | |
Hungary | 0302373 | ⤷ Try a Trial | |
Japan | 3662934 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPIRIVA RESPIMAT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0418716 | SPC/GB02/036 | United Kingdom | ⤷ Try a 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 | 300084 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
0418716 | C300084 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
0418716 | 0290010-8 | Sweden | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |