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Olodaterol hydrochloride; tiotropium bromide - Generic Drug Details

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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-seven patent family members in fifty countries.

One supplier is listed for this compound.

Summary for Generic Name: olodaterol hydrochloride; tiotropium bromide

Tradenames:1
Patents:25
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, 2015RXYesYes6,846,413► subscribeY ► subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes7,284,474► subscribeY ► subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes7,727,984► 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, 20156,726,124► 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, 20156,453,795► 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
6,503,440 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
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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
European Patent Office1426662► subscribe
New Zealand320179► subscribe
Germany50103541► 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
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
00084Netherlands► subscribePRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
9 5009-2014Slovakia► subscribePRODUCT NAME: OLODATEROL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 14/0394/13-S 20131029; FIRST REGISTRATION: MT MA211/00401 20130918
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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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