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Olodaterol hydrochloride; tiotropium bromide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for olodaterol hydrochloride; tiotropium bromide?

Olodaterol hydrochloride; tiotropium bromide is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are twenty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has five hundred and forty-eight patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for Generic Name: olodaterol hydrochloride; tiotropium bromide

Tradenames:1
Patents:26
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packagers: see list1
Clinical Trials: see list1,116
Drug Prices:see low prices
DailyMed Link:olodaterol hydrochloride; tiotropium bromide at DailyMed

Pharmacology for Ingredient: olodaterol hydrochloride; tiotropium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes6,726,124► SubscribeY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes9,027,967► SubscribeY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes8,034,809► Subscribe ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes7,896,264► SubscribeY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes7,396,341► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: olodaterol hydrochloride; tiotropium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20156,176,442► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20157,246,615► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20157,104,470► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20156,149,054► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20156,726,124► Subscribe
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Non-Orange Book Patents for Generic Ingredient: olodaterol hydrochloride; tiotropium bromide

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
7,645,383Microstructured filter► 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
5,610,163 Esters of thienyl carboxylic acids and amino alcohols and their quaternization products► Subscribe
6,503,440 Process for making a container with a pressure equalization opening and containers produced accordingly► 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; tiotropium bromide

Country Document Number Estimated Expiration
Japan2008529754► Subscribe
Eurasian Patent Organization000334► Subscribe
MexicoPA05005081► Subscribe
Poland375270► Subscribe
World Intellectual Property Organization (WIPO)9720590► 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; TIOTROPIUM BROMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2014 00014Denmark► SubscribePRODUCT 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
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
433Luxembourg► SubscribePRODUCT 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
90010-8Sweden► SubscribePRODUCT NAME: TIOTROPIUM, 3BETA-(DI(2-TIENYL)HYDROXIACETOXI)-6BETA,7BETA-EPO XI-8METYL-1ALFAH,5ALFAH-TROPANIUM, ELLER ETT SALT DAERAV; NAT. REGISRTATION NO/DATE: 18094 20020503; FIRST REGISTRATION: NL RVG 26 191 20011009
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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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