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.
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.
Indicators of Generic Entry
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
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 |
| Boehringer Ingelheim | Phase 4 |
Pharmacology for STIOLTO RESPIMAT
| Drug Class | Anticholinergic beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for STIOLTO RESPIMAT
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RESPIRATORY COMPLAINTS
Piston-pumping system having o-ring seal properties
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicaments for the treatment of chronic obstructive pulmonary disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Device for clamping a fluidic component
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Microstructured high pressure nozzle with built-in filter function
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF COPD
Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Device for clamping a fluidic component
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| European Patent Office | 1243299 | Filtre a microstructure (Microstructured filter) | ⤷ Try a Trial |
| Slovakia | 282587 | ⤷ Try a Trial | |
| Slovakia | 12082001 | KARTUŠA NA KVAPALINU, UVOĽNITEĽNÉ SPOJENIE MEDZI KARTUŠOU A PRIPOJOVACÍM DIELOM ODOBERACIEHO PRÍSTROJA, NASÚVATEĽNÝ SPODNÝ DIEL PRÍSTROJA, A JEJ POUŽITIE (CARTRIDGE FOR A LIQUID) | ⤷ Try a Trial |
| Germany | 59608851 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STIOLTO RESPIMAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0418716 | SPC/GB02/036 | United Kingdom | ⤷ Try a Trial | 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 |
| 1562603 | C300650 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: OLODATEROL, OPTISCHE ISOPMEREN; NAT. REGISTRATION NO/DATE: RVG 112058 20131023; FIRST REGISTRATION: |
| 1562603 | C 2014 025 | Romania | ⤷ Try a Trial | 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 |
| 1562603 | 14C0049 | France | ⤷ Try a Trial | 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 |
| >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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