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Last Updated: January 16, 2021

DrugPatentWatch Database Preview

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 nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olodaterol hydrochloride has two hundred and ninety-five patent family members in forty-eight countries.

Summary for olodaterol hydrochloride
International Patents:295
US Patents:19
Tradenames:2
Applicants:1
NDAs:2
Bulk Api Vendors: 22
Clinical Trials: 38
Patent Applications: 9
DailyMed Link:olodaterol hydrochloride at DailyMed
Recent Clinical Trials for olodaterol hydrochloride

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

SponsorPhase
Fraunhofer-Institute of Toxicology and Experimental MedicinePhase 4
Guangzhou Institute of Respiratory DiseaseN/A
Verona Pharma plcPhase 2

See all olodaterol hydrochloride clinical trials

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 STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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   Start Trial   Start Trial
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014   Start Trial   Start Trial
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for olodaterol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1562603 1490016-1 Sweden   Start Trial 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 C 2014 025 Romania   Start Trial 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   Start Trial 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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