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Generated: November 18, 2017

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Umeclidinium bromide - Generic Drug Details

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What are the generic sources for umeclidinium bromide and what is the scope of umeclidinium bromide patent protection?

Umeclidinium bromide
is the generic ingredient in two branded drugs marketed by Glaxo Grp England and Glaxosmithkline, and is included in two NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Umeclidinium bromide has one hundred and fifty-eight patent family members in thirty-nine countries and fourteen supplementary protection certificates in eleven countries.

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

Summary for umeclidinium bromide

Pharmacology for umeclidinium bromide

Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Glaxo Grp England
INCRUSE ELLIPTA
umeclidinium bromide
POWDER;INHALATION205382-001Apr 30, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Glaxo Grp England
INCRUSE ELLIPTA
umeclidinium bromide
POWDER;INHALATION205382-001Apr 30, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxo Grp England
INCRUSE ELLIPTA
umeclidinium bromide
POWDER;INHALATION205382-001Apr 30, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Glaxo Grp England
INCRUSE ELLIPTA
umeclidinium bromide
POWDER;INHALATION205382-001Apr 30, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: umeclidinium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp England
INCRUSE ELLIPTA
umeclidinium bromide
POWDER;INHALATION205382-001Apr 30, 2014► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: umeclidinium 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
8,575,347Muscarinic acetylcholine receptor antagonists► Subscribe
9,144,571Muscarinic acetylcholine receptor antagonists► Subscribe
9,045,469Muscarinic acetylcholine receptor antagonists► Subscribe
8,853,404Muscarinic 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

Country Document Number Estimated Expiration
Japan4960868► Subscribe
South Korea20070015412► Subscribe
Japan2009518093► Subscribe
Israel178152► Subscribe
China101272818► Subscribe
CroatiaP20120832► Subscribe
Israel177042► Subscribe
World Intellectual Property Organization (WIPO)2007068896► Subscribe
Norway20082701► Subscribe
Norway2017018► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00052Denmark► SubscribePRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
C0075France► SubscribePRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
2014038Lithuania► SubscribePRODUCT NAME: UMECLIDINIUM BROMIDIUM; REGISTRATION NO/DATE: EU/1/14/922 20140428
0140032 00132Estonia► SubscribePRODUCT NAME: UMEKLIDIINBROMIID;REG NO/DATE: EU/1/14/922 30.04.2014
1740177/02Switzerland► SubscribePRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
0694Netherlands► SubscribePRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
565Luxembourg► SubscribePRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
90060-9Sweden► SubscribePRODUCT NAME: UMECLIDINIUM BROMIDE; REG. NO/DATE: EU/1/14/922 20140428
00694Netherlands► SubscribePRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
2014038,C1740177Lithuania► SubscribePRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Deloitte
Dow
Cipla
Chinese Patent Office
QuintilesIMS
Julphar
Novartis
Mallinckrodt
Accenture

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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