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Last Updated: December 13, 2024

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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Drug patent expirations by year for SPIRIVA
Drug Prices for SPIRIVA

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Drug Sales Revenue Trends for SPIRIVA

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Recent Clinical Trials for SPIRIVA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Theravance BiopharmaPhase 4
Mylan Inc.Phase 4
Nemours Children's ClinicPhase 2

See all SPIRIVA clinical trials

Pharmacology for SPIRIVA
Drug ClassAnticholinergic
Mechanism of ActionCholinergic 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
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 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
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
Poland 362511 ⤷  Sign Up
Iceland 2360 ⤷  Sign Up
China 101220025 Micronized crystalline tiotropium bromide ⤷  Sign Up
Ukraine 75375 METHOD FOR PRODUCING POWDERY PREPARATIONS FOR INHALING ⤷  Sign Up
Spain 2116353 ⤷  Sign Up
Eurasian Patent Organization 004689 СПОСОБ ПОЛУЧЕНИЯ ПОРОШКОВЫХ КОМПОЗИЦИЙ (METHOD FOR PRODUCING POWDERY FORMULATIONS) ⤷  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 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 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 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
>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.