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Last Updated: May 22, 2022

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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred patent family members in fifty-two countries.

The generic ingredient in SPIRIVA is tiotropium bromide. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.

DrugPatentWatch® Generic Entry Outlook for Spiriva

Spiriva was eligible for patent challenges on January 30, 2008.

Annual sales in 2019 were $3.0bn, indicating a strong incentive for generic entry (peak sales were $4.4bn in 2013).

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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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 nine US patents.

Patents protecting SPIRIVA

Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhalable powder containing tiotropium
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dry powder inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for the administration of an anticholinergic by inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhaler and sieve for an inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for preparing powder formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 See Plans and Pricing See Plans and Pricing
>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
Yugoslavia 27303 See Plans and Pricing
Spain 2227268 See Plans and Pricing
Portugal 95312 PROCESSO PARA A PREPARACAO DE NOVOS TIENILCARBOXILATOS DE AMINOALCOOIS E DOS SEUS PRODUTOS DE QUATERNIZACAO, E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM See Plans and Pricing
Denmark 1487832 See Plans and Pricing
Taiwan I312688 See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 SPC/GB02/036 United Kingdom See Plans and Pricing 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 C300084 Netherlands See Plans and Pricing PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 0290010-8 Sweden See Plans and Pricing 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 05C0039 France See Plans and Pricing PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
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Express Scripts

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