SPIRIVA Drug Patent Profile
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Which patents cover Spiriva, and when can generic versions of Spiriva launch?
Spiriva is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has sixty patent family members in thirty-two countries.
The generic ingredient in SPIRIVA 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
A generic version of SPIRIVA was approved as tiotropium bromide by LUPIN on June 20th, 2023.
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Summary for SPIRIVA
| International Patents: | 60 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 107 |
| Patent Applications: | 3,803 |
| Drug Prices: | Drug price information for SPIRIVA |
| Drug Sales Revenues: | Drug sales revenues for SPIRIVA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SPIRIVA |
| What excipients (inactive ingredients) are in SPIRIVA? | SPIRIVA excipients list |
| DailyMed Link: | SPIRIVA at DailyMed |
Recent Clinical Trials for SPIRIVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mylan Inc. | Phase 4 |
| Theravance Biopharma | Phase 4 |
| Nemours Children's Clinic | Phase 2 |
Pharmacology for SPIRIVA
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Paragraph IV (Patent) Challenges for SPIRIVA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SPIRIVA | Inhalation Powder Capsules | tiotropium bromide | 18 mcg | 021395 | 1 | 2018-05-11 |
US Patents and Regulatory Information for SPIRIVA
SPIRIVA is protected by three US patents.
Patents protecting SPIRIVA
Dry powder inhaler
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method for the administration of an anticholinergic by inhalation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Inhaler and sieve for an inhaler
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 | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | AB | 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 | 021936-002 | 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 | |||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPIRIVA
See the table below for patents covering SPIRIVA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Ireland | 903342 | ⤷ Sign Up | |
| South Africa | 200302500 | Crystalline monohydrate, method for producing the same and the use thereof in the production of a medicament. | ⤷ Sign Up |
| Argentina | 034389 | MONOHIDRATO CRISTALINO DE BROMURO DE TIOTROPIO, PROCEDIMIENTO PARA SU PREPARACION, SU UTILIZACIÓN PARA LA PREPARACION DE UN MEDICAMENTO, UN MEDICAMENTO QUE LO CONTIENE, LOS HIDRATOS CRISTALINOS DEL BROMURO DE TIOTROPIO Y UN PROCEDIMIENTO PARA PREPARACION DE ESTOS HIDRATOS CRISTALINOS | ⤷ Sign Up |
| Norway | 333719 | ⤷ Sign Up | |
| European Patent Office | 1487832 | MICRONISAT CRISTALLIN DE BROMURE DE TIOTROPIUM (MICRONIZED CRYSTALLINE TIOTROPIUM BROMIDE) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPIRIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0418716 | 300084 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
| 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 | 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 | 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 |
| >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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