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Last Updated: March 19, 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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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
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

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
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
Taiwan I345975 ⤷  Try a Trial
Spain 2747779 ⤷  Try a Trial
Portugal 95312 PROCESSO PARA A PREPARACAO DE NOVOS TIENILCARBOXILATOS DE AMINOALCOOIS E DOS SEUS PRODUTOS DE QUATERNIZACAO, E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM ⤷  Try a Trial
Eurasian Patent Organization 200300457 ⤷  Try a Trial
Slovenia 1326585 ⤷  Try a Trial
Iceland 6772 ⤷  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
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
0418716 C300084 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

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