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Last Updated: May 25, 2022

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 thirteen patents protecting this drug.

This drug has one hundred and ninety-six 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.

Indicators of Generic Entry

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Summary for STIOLTO RESPIMAT
International Patents:196
US Patents:13
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 3
Drug Prices: Drug price information for STIOLTO RESPIMAT
What excipients (inactive ingredients) are in STIOLTO RESPIMAT?STIOLTO RESPIMAT excipients list
DailyMed Link:STIOLTO RESPIMAT at DailyMed
Drug patent expirations by year for STIOLTO RESPIMAT
Drug Prices for STIOLTO RESPIMAT

See drug prices for STIOLTO RESPIMAT

DrugPatentWatch® Estimated Generic Entry Opportunity 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

US Patents and Regulatory Information for STIOLTO RESPIMAT

STIOLTO RESPIMAT is protected by thirteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STIOLTO RESPIMAT is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Medicaments for the treatment of chronic obstructive pulmonary disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Piston-pumping system having o-ring seal properties
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Enantiomerically pure beta agonists, process for the manufacture thereof, and use thereof as medicaments
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicaments for the treatment of chronic obstructive pulmonary disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicaments for the treatment of chronic obstructive pulmonary disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Device for clamping a fluidic component
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Microstructured high pressure nozzle with built-in filter function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COPD

Medicaments for the treatment of chronic obstructive pulmonary disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COPD

Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

International Patents for STIOLTO RESPIMAT

When does loss-of-exclusivity occur for STIOLTO RESPIMAT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1969
Estimated Expiration: See Plans and Pricing

Patent: 7241
Estimated Expiration: See Plans and Pricing

Australia

Patent: 03285326
Estimated Expiration: See Plans and Pricing

Austria

Patent: 0569
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 16264
Estimated Expiration: See Plans and Pricing

Patent: 0316264
Estimated Expiration: See Plans and Pricing

Canada

Patent: 06082
Estimated Expiration: See Plans and Pricing

China

Patent: 13914
Estimated Expiration: See Plans and Pricing

Patent: 1735166
Estimated Expiration: See Plans and Pricing

Patent: 1817800
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 70670
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0050432
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 10500
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 62603
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 055774
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8665
Estimated Expiration: See Plans and Pricing

Patent: 0500715
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 62603
Estimated Expiration: See Plans and Pricing

Patent: 25338
Estimated Expiration: See Plans and Pricing

Germany

Patent: 253282
Estimated Expiration: See Plans and Pricing

Patent: 311502
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 400011
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7900
Estimated Expiration: See Plans and Pricing

Japan

Patent: 17138
Estimated Expiration: See Plans and Pricing

Patent: 06508140
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 562603
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 433
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 6034
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05005081
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 354
Estimated Expiration: See Plans and Pricing

Patent: 3608
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0650
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0661
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4314
Estimated Expiration: See Plans and Pricing

Patent: 14005
Estimated Expiration: See Plans and Pricing

Patent: 052883
Estimated Expiration: See Plans and Pricing

Peru

Patent: 040694
Estimated Expiration: See Plans and Pricing

Poland

Patent: 2238
Estimated Expiration: See Plans and Pricing

Patent: 5270
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 62603
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 607
Estimated Expiration: See Plans and Pricing

Patent: 050361
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 62603
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0502246
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1092247
Estimated Expiration: See Plans and Pricing

Patent: 050075013
Estimated Expiration: See Plans and Pricing

Spain

Patent: 26878
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 43812
Estimated Expiration: See Plans and Pricing

Patent: 0423943
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 276
Estimated Expiration: See Plans and Pricing

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

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

Country Patent Number Title Estimated Expiration
Israel 172461 See Plans and Pricing
Canada 2551891 DISPOSITIF, SOUS FORME MINIATURE, DESTINE A PRODUIRE UNE PRESSION ELEVEE DANS UN FLUIDE A ATOMISER (DEVICE OF MINIATURISED CONSTRUCTION FOR PRODUCING HIGH PRESSURE IN A FLUID TO BE ATOMISED) See Plans and Pricing
Norway 334314 See Plans and Pricing
Argentina 004849 MECANISMO TENSOR CON BLOQUEO PARA UN ELEMENTO ACCIONADOR DE SALIDA ACTIVADO A RESORTE Y DISPOSITIVO PARA COMPRIMIR Y ATOMIZAR UN FLUIDO QUE LO COMPRENDE See Plans and Pricing
New Zealand 538925 Blocking device for a sprung lock with a spring operation See Plans and Pricing
Turkey 200000853 See Plans and Pricing
Australia 730797 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STIOLTO RESPIMAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1562603 513 Finland See Plans and Pricing
1562603 C20140010 00101 Estonia See Plans and Pricing PRODUCT NAME: OLODATEROOL;REG NO/DATE: EE 825513 03.10.2013
1562603 14C0049 France See Plans and Pricing PRODUCT NAME: OLODATEROL, SES ISOMERES OPTIQUES INDIVIDUELS, MELANGES D'ENANTIOMERES INDIVIDUELS OU RACEMATE, SES SELS D'ADDITION D'ACIDE AVEC DES ACIDES PHARMACOLOGIQUEMENT ACCEPTABLES, AINSI QUE DES SOLVATES ET OU HYDRATES, EN PARTICULIER OLODATEROL OU CHLORHYDRATE D'OLODATEROL; NAT. REGISTRATION NO/DATE: NL42395 20140522; FIRST REGISTRATION: MT - MA211/00401 20130918
1562603 92433 Luxembourg See Plans and Pricing PRODUCT NAME: OLODATEROL,SES ISOMERES OPTIQUES INDIVIDUELS,MELANGES D ENANTIOMERES INDIVIDUELS OU DE RACEMATES,SES SELS D ADDITION D ACIDE AVEC DES ACIDES PHARMACEUTIQUEMENT ACCEPTABLES,AINSI QUE SES SOLVATES ET/OU SES HYDRATES,EN PARTICULIER L OLODATEROL ET LE CHLORHYDRATE D OLODATEROL
1562603 2014/016 Ireland See Plans and Pricing PRODUCT NAME: OLODATEROL, OPTICAL ISOMERS THEREOF, MIXTURES OF ISOMERS THEREOF, ACID ADDITION SALTS THEREOF WITH PHARMACOLOGICALLY ACCEPTABLE ACIDS, AS WELL AS SOLVATES AND/OR HYDRATES THEREOF, IN PARTICULAR OLODATEROL AND OLODATEROL HYDROCHLORIDE.; NAT REGISTRATION NO/DATE: PA0775/006/001 20131018; FIRST REGISTRATION NO/DATE: MA211/00401 20130918
1562603 SPC/GB14/023 United Kingdom See Plans and Pricing PRODUCT NAME: OLODATEROL OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: MT MA 211/00401 20130918; UK PL 14598/0093 20131010
1562603 C300650 Netherlands See Plans and Pricing PRODUCT NAME: OLODATEROL, OPTISCHE ISOPMEREN; NAT. REGISTRATION NO/DATE: RVG 112058 20131023; FIRST REGISTRATION:
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Mallinckrodt
Medtronic
Express Scripts
Colorcon

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.