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Last Updated: November 12, 2019

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Olodaterol hydrochloride - Generic Drug Details

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What are the generic 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 twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olodaterol hydrochloride has two hundred and eighty-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for olodaterol hydrochloride
International Patents:289
US Patents:23
Tradenames:2
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 18
Clinical Trials: 36
Patent Applications: 9
DailyMed Link:olodaterol hydrochloride at DailyMed
Recent Clinical Trials for olodaterol hydrochloride

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

SponsorPhase
Guangzhou Institute of Respiratory DiseaseN/A
Verona Pharma plcPhase 2
HealthcorePhase 4

See all olodaterol hydrochloride clinical trials

Pharmacology for olodaterol hydrochloride
Synonyms for olodaterol hydrochloride
(R)-6-hydroxy-8-(1-hydroxy-2-((1-(4-methoxyphenyl)-2-methylpropan-2-yl)amino)ethyl)-2H-benzo[b][1,4]oxazin-3(4H)-one hydrochloride
2H-1,4-benzoxazin-3(4H)-one, 6-hydroxy-8-((1R)-1-hydroxy-2-((2-(4-methoxyphenyl)- 1,1-dimethylethyl)amino)ethyl)-, hydrochloride (1:1)
6-Hydroxy-8-((1R)-1-hydroxy-2-((2-(4-methoxyphenyl)-1,1-dimethylethyl)amino)ethyl)- 2H-1,4-benzoxazin-3(4H)-one hydrochloride
6-hydroxy-8-[(1R)-1-hydroxy-2-[[1-(4-methoxyphenyl)-2-methylpropan-2-yl]amino]ethyl]-4H-1,4-benzoxazin-3-one hydrochloride
6-hydroxy-8-[(1R)-1-hydroxy-2-{[1-(4-methoxyphenyl)-2-methylpropan-2-yl]amino}ethyl]-2H-1,4-benzoxazin-3(4H)-one hydrochloride
6-hydroxy-8-{(1r)-1-hydroxy-2-{[1-(4-methoxyphenyl)-2-methylpropan-2-yl]amino}ethyl}-4h-1,4-benzoxazin-3-one hydrochloride
65R445W3V9
869477-96-3
AC-29884
AKOS030524628
BCP16765
BI 1744 CL
BI 1744 hydrochloride
Bi-1744-cl
CHEBI:83309
CHEMBL2105743
D10020
N-[(2R)-2-hydroxy-2-(6-hydroxy-3-oxo-3,4-dihydro-2H-1,4-benzoxazin-8-yl)ethyl]-1-(4-methoxyphenyl)-2-methylpropan-2-aminium chloride
Olodaterol HCl
Olodaterol hydrochloride (JAN/USAN)
Olodaterol hydrochloride [usan]
Olodaterol(BI-1744) hydrochloride
SB16711
SCHEMBL560669
Striverdi Respimat
Striverdi respimat (TN)
UNII-65R445W3V9

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 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
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 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 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
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
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 C01562603/01 Switzerland   Start Trial PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014
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 92433 Luxembourg   Start Trial PRODUCT NAME: OLODATEROL,SES ISOMERES OPTIQUES INDIVIDUELS,MELANGES D ENANTIOMERES INDIVIDUELS OU DE RACEMATES,SES SELS D ADDITION D ACIDE AVEC DES ACIDES PHARMACEUTIQUEMENT ACCEPTABLES,AINSI QUE SES SOLVATES ET/OU SES HYDRATES,EN PARTICULIER L OLODATEROL ET LE CHLORHYDRATE D OLODATEROL
1562603 122014000018 Germany   Start Trial PRODUCT NAME: OLODATEROL, OPTISCHE ISOMERE DAVON, MISCHUNGEN VON ISOMEREN DAVON, SAEUREADDITIONSSALZE DAVON MIT PHARMAKOLOGISCH UNBEDENKLICHEN SAEUREN, SOWIE SOLVATE UND/ODER HYDRATE DAVON, INSBESONDERE OLODATEROL UND OLODATEROLHYDROCHLORID; NAT. REGISTRATION NO/DATE: 87146.00.00 20131126; FIRST REGISTRATION: MALTA 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
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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