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Umeclidinium bromide; vilanterol trifenatate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for umeclidinium bromide; vilanterol trifenatate?

Umeclidinium bromide; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and twenty-nine patent family members in forty countries.

There is one drug master file entry for umeclidinium bromide; vilanterol trifenatate. One supplier is listed for this compound.

Summary for Generic Name: umeclidinium bromide; vilanterol trifenatate

Tradenames:1
Patents:14
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packagers: see list1
Clinical Trials: see list96
Drug Prices:see low prices
DailyMed Link:umeclidinium bromide; vilanterol trifenatate at DailyMed

Pharmacology for Ingredient: umeclidinium bromide; vilanterol trifenatate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes8,161,968► SubscribeY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes8,183,257► Subscribe ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes9,333,310► SubscribeY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes7,776,895► SubscribeY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes8,746,242► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: umeclidinium bromide; vilanterol trifenatate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 20135,873,360► Subscribe
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Non-Orange Book Patents for Generic Ingredient: umeclidinium bromide; vilanterol trifenatate

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
9,144,571Muscarinic acetylcholine receptor antagonists► Subscribe
8,853,404Muscarinic acetylcholine receptor antagonists► Subscribe
7,982,067Phenethanolamine derivatives for treatment of respiratory diseases► Subscribe
7,361,787Phenethanolamine derivatives for treatment of respiratory diseases► Subscribe
9,045,469Muscarinic acetylcholine receptor antagonists► 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: umeclidinium bromide; vilanterol trifenatate

Country Document Number Estimated Expiration
South Korea20040035788► Subscribe
Mexico2007001956► Subscribe
World Intellectual Property Organization (WIPO)2007012871► Subscribe
Japan4825138► Subscribe
Japan2006528500► 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: UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90060-9Sweden► SubscribePRODUCT NAME: UMECLIDINIUM BROMIDE; REG. NO/DATE: EU/1/14/922 20140428
1425001/02Switzerland► SubscribePRODUCT NAME: VILANTEROL UND FLUTICASON FUROAT; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
2014 00021Denmark► SubscribePRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
1425001/01Switzerland► SubscribePRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
1740177/03Switzerland► SubscribePRODUCT NAME: UMECLIDINIUM BROMID; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
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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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