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 eight patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty-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.
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
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for STIOLTO RESPIMAT?
- What are the global sales for STIOLTO RESPIMAT?
- What is Average Wholesale Price for STIOLTO RESPIMAT?
Summary for STIOLTO RESPIMAT
International Patents: | 156 |
US Patents: | 8 |
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 | Phase 4 |
HealthCore-NERI | Phase 4 |
Los Angeles Biomedical Research Institute | 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 eight US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of STIOLTO RESPIMAT is ⤷ Try for Free.
This potential generic entry date is based on patent 7,727,984.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 7,220,742 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | 7,396,341*PED | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | 7,727,984 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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 | 7,896,264 | ⤷ Try for Free |
Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | 6,846,413*PED | ⤷ Try for Free |
Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | 5,964,416 | ⤷ Try for Free |
>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 |
---|---|---|---|
Saudi Arabia | 1359 | خرطوشة سوائل | ⤷ Try for Free |
Japan | 2005537130 | ⤷ Try for Free | |
Estonia | 03427 | Pihusti sõlm ja selle kasutamine | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STIOLTO RESPIMAT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1562603 | 1490016-1 | Sweden | ⤷ Try for Free | 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 |
0418716 | SPC/GB02/036 | United Kingdom | ⤷ Try for Free | 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 | C01562603/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for STIOLTO RESPIMAT
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