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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Questions you can ask:
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Summary for STIOLTO RESPIMAT
| International Patents: | 194 |
| US Patents: | 9 |
| 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 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for STIOLTO RESPIMAT |
| What excipients (inactive ingredients) are in STIOLTO RESPIMAT? | STIOLTO RESPIMAT excipients list |
| DailyMed Link: | STIOLTO RESPIMAT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for STIOLTO RESPIMAT
*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 | Phase 4 |
| HealthCore-NERI | Phase 4 |
| Boehringer Ingelheim | Phase 4 |
Pharmacology for STIOLTO RESPIMAT
| Drug Class | Anticholinergic beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
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 | |||
| >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 |
| >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 |
|---|---|---|---|
| Brazil | PI0412043 | bocal de alta pressão microestruturado com função de filtro embutida | ⤷ Sign Up |
| Canada | 2551999 | 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) | ⤷ Sign Up |
| New Zealand | 320158 | Device for mounting a component exposed to a pressurized fluid | ⤷ 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 | 14C0049 | France | ⤷ Sign Up | 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 | C 2014 025 | Romania | ⤷ Sign Up | PRODUCT NAME: OLODATEROL, IZOMERI OPTICI INDIVIDUALI AI ACESTUIA,AMESTECURI DE ENANTIOMERI INDIVIDUALI SAU RACEMATI, SARURILE DE ADITIE ACIDA ALE ACESTORA CU ACIZI ACCEPTABILIFARMACOLOGIC, CA SI SOLVATI SI/SAU HIDRATI AI ACESTORA, IN SPECIAL OLODATEROL SI CLORHI DRAT DE OLODATEROL -6-HIDROXI-2-{[1-(4-METOXIFENIL)-1,1-DIMETILETIL]AMINO}ETIL]-2H-1,4-BENZOXAZIN-3(4H)-ONA(CACLORHIDRAT); NATIONAL AUTHORISATION NUMBER: 6414/2014/01, 6414/2014/02, 6414/2014/03, 6414/2014/04; DATE OF NATIONAL AUTHORISATION: 20140507; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MA211/00401; DATE OF FIRST AUTHORISATION IN EEA: 20130918 |
| 0418716 | SPC/GB02/036 | United Kingdom | ⤷ Sign Up | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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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