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Last Updated: May 12, 2021

DrugPatentWatch Database Preview

SPIRIVA RESPIMAT Drug Profile

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When do Spiriva Respimat patents expire, and what generic alternatives are available?

Spiriva Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and sixty-nine patent family members in forty-four countries.

The generic ingredient in SPIRIVA RESPIMAT 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 Respimat

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 4, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SPIRIVA RESPIMAT
Drug patent expirations by year for SPIRIVA RESPIMAT
Drug Prices for SPIRIVA RESPIMAT

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for SPIRIVA RESPIMAT
Generic Entry Date for SPIRIVA RESPIMAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SPRAY, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SPIRIVA RESPIMAT

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

SponsorPhase
Rho, Inc.Phase 2
Nephron Pharmaceuticals CorporationPhase 2
Shanghai Zhongshan HospitalN/A

See all SPIRIVA RESPIMAT clinical trials

Pharmacology for SPIRIVA RESPIMAT
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

US Patents and Regulatory Information for SPIRIVA RESPIMAT

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 RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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 RESPIMAT

Supplementary Protection Certificates for SPIRIVA RESPIMAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0418716 300084 Netherlands   Get Started for $10 PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 0290010-8 Sweden   Get Started for $10 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   Get Started for $10 PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
0418716 C300084 Netherlands   Get Started for $10 PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 SPC/GB02/036 United Kingdom   Get Started for $10 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
Express Scripts
Merck
McKinsey
McKesson

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