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Last Updated: November 7, 2024

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STIOLTO RESPIMAT Drug Patent Profile


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When do Stiolto Respimat patents expire, and when can generic versions of Stiolto Respimat launch?

Stiolto Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in STIOLTO RESPIMAT is olodaterol hydrochloride; tiotropium bromide. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride; tiotropium bromide profile page.

DrugPatentWatch® Generic Entry Outlook for Stiolto Respimat

Stiolto Respimat was eligible for patent challenges on July 31, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 19, 2027. This may change due to patent challenges or generic licensing.

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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Drug patent expirations by year for STIOLTO RESPIMAT
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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for STIOLTO RESPIMAT
Generic Entry Date for STIOLTO 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 STIOLTO RESPIMAT

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

SponsorPhase
HealthCore-NERIPhase 4
HealthcorePhase 4
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterPhase 4

See all STIOLTO RESPIMAT clinical trials

Pharmacology for STIOLTO RESPIMAT
Paragraph IV (Patent) Challenges for STIOLTO RESPIMAT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
STIOLTO RESPIMAT Inhalation Spray olodaterol hydrochloride; tiotropium bromide 2.5 mcg/2.5 mcg per spray 206756 1 2024-05-24

US Patents and Regulatory Information for STIOLTO RESPIMAT

STIOLTO RESPIMAT is protected by nine US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STIOLTO RESPIMAT is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting STIOLTO RESPIMAT

Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF RESPIRATORY COMPLAINTS

Piston-pumping system having o-ring seal properties
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Medicaments for the treatment of chronic obstructive pulmonary disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Device for clamping a fluidic component
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Microstructured high pressure nozzle with built-in filter function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF COPD

Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Device for clamping a fluidic component
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 STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 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 STIOLTO RESPIMAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for STIOLTO RESPIMAT

See the table below for patents covering STIOLTO RESPIMAT around the world.

Country Patent Number Title Estimated Expiration
Australia 642913 ⤷  Sign Up
Canada 2445256 AJUTAGE DE PULVERISATION AVEC FILTRE, ET DISPOSITIF DE PULVERISATION LES INCORPORANT (ATOMISING NOZZLE AND FILTER AND SPRAY GENERATING DEVICE) ⤷  Sign Up
Japan 5015896 ⤷  Sign Up
Slovenia 1706210 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STIOLTO RESPIMAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1562603 122014000018 Germany ⤷  Sign Up PRODUCT NAME: OLODATEROL, OPTISCHE ISOMERE DAVON, MISCHUNGEN VON ISOMEREN DAVON, SAEUREADDITIONSSALZE DAVON MIT PHARMAKOLOGISCH UNBEDENKLICHEN SAEUREN, SOWIE SOLVATE UND/ODER HYDRATE DAVON, INSBESONDERE OLODATEROL UND OLODATEROLHYDROCHLORID; NAT. REGISTRATION NO/DATE: 87146.00.00 20131126; FIRST REGISTRATION: MALTA MA 211/00401 20130918
1562603 1490016-1 Sweden ⤷  Sign Up PRODUCT NAME: OLODATEROL, INDIVIDUELLA OPTISKA ISOMERER DAERAV, BLANDNINGAR AV DE SEPARATA ENANTIOMERERNA ELLER RACEMATEN DAERAV, SYRA ADDITIONSSALTER DAERAV MED FARMAKOLOGISKT GODTAGBARA SYROR SAVAEL SOM SOLVATER OCH/ELLER HYDRATER DAERAV, SAERSKILT OLODATEROL OCH OLODATEROLHYDROKLORID; NAT. REG. NO/DATE: MT-NR 48116 20131114; FIRST REG.: MT MA 211/00401 20130918
1562603 21/2014 Austria ⤷  Sign Up PRODUCT NAME: OLODATEROL, DESSEN SAEUREHAELTIGEN SALZE MIT PHARMAKOLOGISCH VERTRAEGLICHEN SAEUREN, IM BESONDEREN OLODATEROL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 135232 20131125; FIRST REGISTRATION: MT MA211/00401 20130918
1562603 132014902316088 Italy ⤷  Sign Up PRODUCT NAME: OLODATEROLO, SUOI SINGOLI ISOMERI OTTICI, MISCELE DEI SINGOLI ENANTIOMERI O DI RACEMATI, SUOI SALI DI ADDIZIONE CON ACIDI FARMACOLOGICAMENTE ACCETTABILI NONCHE' SUOI SOLVATI E/O IDRATI, IN PARTICOLARE OLODATEROLO E OLODATEROLO CLORIDRATO(STRIVERDI RESPIMAT); AUTHORISATION NUMBER(S) AND DATE(S): MA211/00401, 20130918;042432017-029-031-043, 20140618
>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.