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Last Updated: June 2, 2024

OLODATEROL HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for olodaterol hydrochloride and what is the scope of freedom to operate?

Olodaterol hydrochloride is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olodaterol hydrochloride has one hundred and ninety-four patent family members in forty countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OLODATEROL HYDROCHLORIDE
Generic Entry Date for OLODATEROL HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
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 OLODATEROL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boehringer IngelheimN/A
Yonsei UniversityN/A
Fraunhofer-Institute of Toxicology and Experimental MedicinePhase 4

See all OLODATEROL HYDROCHLORIDE clinical trials

Pharmacology for OLODATEROL HYDROCHLORIDE

US Patents and Regulatory Information for OLODATEROL HYDROCHLORIDE

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 ⤷  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 STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 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 STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 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 OLODATEROL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OLODATEROL HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
South Africa 200607152 Novel enantiomerically pure beta-agonists, method for the production and the use thereof in the form of a drug ⤷  Sign Up
European Patent Office 1426662 Pompe à piston (Piston pump) ⤷  Sign Up
Argentina 041060 DISPOSITIVO BLOQUEADOR PARA UN MECANISMO TENSOR DE BLOQUEO CON UNA TOMA DE FUERZA ACCIONADA POR RESORTE ⤷  Sign Up
Norway 334314 ⤷  Sign Up
South Africa 200604658 Device for holding a fluidic component ⤷  Sign Up
Germany 102004001451 Vorrichtung zum Haltern eines fluidischen Bauteiles ⤷  Sign Up
Malaysia 136755 MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH BUILT-IN FILTER FUNCTION ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OLODATEROL HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1562603 2014/016 Ireland ⤷  Sign Up 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 ⤷  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
1562603 CR 2014 00014 Denmark ⤷  Sign Up 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 300650 Netherlands ⤷  Sign Up PRODUCT NAME: OLODATEROL, HET R-ENANTIOMEER DAARVAN, MENGSELS VAN ISOMEREN DAARVAN, ZUURADDITIEZOUTEN MET FARMACOLOGISCH AANVAARDBARE ZUREN DAARVAN, EVENALS SOLVATEN EN/OF HYDRATEN DAARVAN, IN HET BIJZONDER OLODATEROL EN OLODATEROLHYDROCHLORIDE; REGISTRATION NO/DATE: RVG 112058 20131023
1562603 513 Finland ⤷  Sign Up
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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