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Umeclidinium bromide - Generic Drug Details

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

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 thirty-seven patent family members in thirty-seven countries.

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

Summary for Generic Name: umeclidinium bromide

Tradenames:2
Patents:15
Applicants:2
NDAs:2
Drug Master File Entries: see list1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list12
Clinical Trials: see list92
Patent Applications: see list129
Drug Prices:see low prices
DailyMed Link:umeclidinium bromide at DailyMed

Pharmacology for Ingredient: umeclidinium bromide

Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
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, 2013RXYesYes7,439,393► SubscribeYY ► Subscribe
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 2013RXYesYes7,776,895► SubscribeY ► Subscribe
Glaxo Grp England
INCRUSE ELLIPTA
umeclidinium bromide
POWDER;INHALATION205382-001Apr 30, 2014RXYesYes► Subscribe► Subscribe
Glaxo Grp England
INCRUSE ELLIPTA
umeclidinium bromide
POWDER;INHALATION205382-001Apr 30, 2014RXYesYes8,113,199► 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp England
INCRUSE ELLIPTA
umeclidinium bromide
POWDER;INHALATION205382-001Apr 30, 20145,873,360► 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
8,853,404Muscarinic acetylcholine receptor antagonists► Subscribe
9,144,571Muscarinic acetylcholine receptor antagonists► 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

Country Document Number Estimated Expiration
TaiwanI455735► Subscribe
Denmark1740177► Subscribe
South Korea101387352► Subscribe
Eurasian Patent Organization201100019► Subscribe
World Intellectual Property Organization (WIPO)2005079727► 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
2014038,C1740177Lithuania► SubscribePRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428
1740177/02Switzerland► SubscribePRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
00694Netherlands► SubscribePRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
8 50012-2014Slovakia► SubscribePRODUCT NAME: UMEKLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001 - EU/1/14/922/003 20140430
C0075France► SubscribePRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
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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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