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Last Updated: November 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 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
>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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for olodaterol hydrochloride

Country Patent Number Title Estimated Expiration
Colombia 5700803 BOQUILLA MICROESTRUCTURADA DE ALTA PRESION CON FUNCION DE FILTRO INCORPORADA ⤷  Sign Up
European Patent Office 1641569 AJUTAGE HAUTE PRESSION MICROSTRUCTURE COMPORTANT UNE FONCTION DE FILTRAGE INTEGREE (MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION) ⤷  Sign Up
Peru 20050026 BOQUILLA MICROESTRUCTURADA DE ALTA PRESION CON FUNCION DE FILTRO INCORPORADA ⤷  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 PA2014012,C1562603 Lithuania ⤷  Sign Up 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
1562603 C 2014 025 Romania ⤷  Sign Up 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 C01562603/01 Switzerland ⤷  Sign Up PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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