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Generated: September 23, 2017

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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 olodaterol hydrochloride 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 thirty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olodaterol hydrochloride has five hundred and eighteen patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for Generic Name: olodaterol hydrochloride

Tradenames:2
Patents:33
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list7
Clinical Trials: see list2,309
Patent Applications: see list9
Drug Prices:see low prices
DailyMed Link:olodaterol hydrochloride at DailyMed

Pharmacology for Ingredient: 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;INHALATION203108-001Jul 31, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: olodaterol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014► Subscribe► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014► Subscribe► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014► Subscribe► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014► Subscribe► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014► Subscribe► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014► Subscribe► Subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 2014► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: olodaterol hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,503,440 Process for making a container with a pressure equalization opening and containers produced accordingly► Subscribe
6,497,373 Device for producing high pressure in a fluid in miniature► Subscribe
6,402,055 Device for producing high pressure in a fluid in miniature► Subscribe
7,645,383Microstructured filter► Subscribe
7,451,884Container provided with a pressure equalization opening► Subscribe
6,918,547 Device for producing high pressure in a fluid in miniature► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: olodaterol hydrochloride

Country Document Number Estimated Expiration
Colombia5570670► Subscribe
World Intellectual Property Organization (WIPO)2005065836► Subscribe
Germany10017443► Subscribe
Hungary0302373► Subscribe
Czech Republic9801015► Subscribe
Bulgaria105785► Subscribe
Slovakia284288► Subscribe
Taiwan200418541► Subscribe
Bulgaria102360► Subscribe
Slovakia282587► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OLODATEROL HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014012Lithuania► SubscribePRODUCT NAME: OLODATEROLUM; REGISTRATION NO/DATE: LT/1/13/3429/001 LT/1/13/3429/003 LT/1/13/3429/003 LT/1/13/3429/004 20131031
0140010 00101Estonia► SubscribePRODUCT NAME: OLODATEROOL;REG NO/DATE: EE 825513 03.10.2013
9 5009-2014Slovakia► SubscribePRODUCT NAME: OLODATEROL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 14/0394/13-S 20131029; FIRST REGISTRATION: MT MA211/00401 20130918
1562603/01Switzerland► SubscribePRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014
/2014Austria► SubscribePRODUCT 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
00650Netherlands► SubscribePRODUCT NAME: OLODATEROL, OPTISCHE ISOPMEREN; NAT. REGISTRATION NO/DATE: RVG 112058 20131023; FIRST REGISTRATION:
14/016Ireland► SubscribePRODUCT 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
0650Netherlands► SubscribePRODUCT NAME: OLODATEROL, OPTISCHE ISOPMEREN 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
2014012,C1562603Lithuania► SubscribePRODUCT 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
90016-1Sweden► SubscribePRODUCT 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
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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Accenture
Farmers Insurance
Mallinckrodt
Fish and Richardson
Dow
Cipla
Teva
Chubb
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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