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
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 |
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
| Sponsor | Phase |
|---|---|
| HealthCore-NERI | Phase 4 |
| Healthcore | Phase 4 |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for STIOLTO RESPIMAT
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
| 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 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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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.
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