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:
- What is the 5 year forecast for STIOLTO RESPIMAT?
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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
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 |
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 | |||
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 |