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STIOLTO RESPIMAT Drug Profile
» See Plans and Pricing
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 fifteen patents protecting this drug.
This drug has two hundred and ninety-five patent family members in forty-eight 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.
US ANDA Litigation and 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: | 295 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 3 |
| Drug Prices: | Drug price information for STIOLTO RESPIMAT |
| DailyMed Link: | STIOLTO RESPIMAT at DailyMed |
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 | Phase 4 |
| Boehringer Ingelheim | Phase 4 |
| Los Angeles Biomedical Research Institute | Phase 4 |
Pharmacology for STIOLTO RESPIMAT
| Drug Class | Anticholinergic beta2-Adrenergic Agonist |
| Mechanism of Action | Cholinergic Antagonists Adrenergic beta2-Agonists |
US Patents and Regulatory Information for STIOLTO RESPIMAT
Expired US Patents for STIOLTO RESPIMAT
International Patents for STIOLTO RESPIMAT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1789405 | Start Trial |
| Croatia | P960448 | Start Trial |
| Croatia | P980526 | Start Trial |
| Czech Republic | 295757 | Start Trial |
| Austria | 103914 | Start Trial |
| Australia | 1303597 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007128381 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for STIOLTO RESPIMAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1562603 | CR 2014 00014 | Denmark | Start Trial | PRODUCT NAME: OLODATEROL, OPTISKE ISOMERER DERAF, BLANDINGER AF ISOMERER DERAF, SYREADDITIONSSALTE DERAF MED FARMAKOLGISK HARMLOESE SYRER, SAVEL SOM SOLVATER OG/ELLER HYDRATER DERAF, SAERLIGT OLODATEROL OG OLODATEROL HYDROCHLORID; NAT. REG. NO/DATE: 50975 20131014; FIRST REG. NO/DATE: MA 211/00401 20130918 |
| 1562603 | PA2014012,C1562603 | Lithuania | Start Trial | PRODUCT NAME: OLODATEROLIS, JO OPTINIAI IZOMERAI, JO ATSKIRU ENANTIOMERU ARBA RACEMATU MISINIAI, JO RUGSTIES ADITYVINES DRUSKOS SU FRAMAKOLOGINIU POZIURIU PRIIMTINOMIS RUGSTIMIS, O TAIP PAT JO SOLVATAI IR/ARBA HIDRATAI, KONKRECIAI OLODATEROLIS IR OLODATEROLIO CHLORIDAS; NAT. REGISTRATION NO/DATE: LT/1/13/3429/001, LT/1/13/3429/002, LT/1/13/3429/003, LT/1/13/3429/004 20131031; FIRST REGISTRATION: MA211/00401 20130918 |
| 0418716 | 300084 | Netherlands | Start Trial | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
| 0418716 | 0290010-8 | Sweden | Start Trial | PRODUCT NAME: TIOTROPIUM, 3BETA-(DI(2-TIENYL)HYDROXIACETOXI)-6BETA,7BETA-EPO XI-8METYL-1ALFAH,5ALFAH-TROPANIUM, ELLER ETT SALT DAERAV; NAT. REGISRTATION NO/DATE: 18094 20020503; FIRST REGISTRATION: NL RVG 26 191 20011009 |
| 1562603 | 2014/016 | Ireland | Start Trial | 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 | 21/2014 | Austria | Start Trial | 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 |
| 0418716 | C300084 | Netherlands | Start Trial | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
