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.
Summary for SPIRIVA
| International Patents: | 60 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Clinical Trials: | 107 |
| Patent Applications: | 3,451 |
| 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 |
|---|---|
| Theravance Biopharma | Phase 4 |
| Mylan Inc. | Phase 4 |
| Nemours Children's Clinic | Phase 2 |
Pharmacology for SPIRIVA
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for SPIRIVA
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for the administration of an anticholinergic by inhalation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Inhaler and sieve for an inhaler
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 | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | AB | 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 | 021936-002 | Sep 15, 2015 | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Argentina | 031819 | POLVOS PARA INHALACION QUE CONTIENEN TIOTROPIO, UN PROCEDIMIENTO PARA PREPARARLOS, LA UTILIZACION DE LOS MISMOS PARA PREPARAR UN MEDICAMENTO Y LAS CAPSULAS PARA INHALACION QUE LOS CONTIENEN | ⤷ Try a Trial |
| Algeria | 3477 | ⤷ Try a Trial | |
| Hungary | 226830 | THIOTROPIUM BROMIDE MONOHYDRATE, METHOD FOR PRODUCING THE SAME AND A PHARMACEUTICAL COMPOSITION CONTAINING THE SAME | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPIRIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0418716 | 05C0039 | France | ⤷ Try a Trial | PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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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