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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Covington
US Department of Justice
Moodys
Fuji
Chubb
Colorcon
Merck
Teva

Generated: July 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203975

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NDA 203975 describes ANORO ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the ANORO ELLIPTA profile page.

The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.
Summary for 203975
Generic Entry Opportunity Date for 203975
Generic Entry Date for 203975*:
Constraining patent/regulatory exclusivity:
Dosage::
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 203975
Suppliers and Packaging for NDA: 203975
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975 NDA GlaxoSmithKline LLC 0173-0869 N 0173-0869-06
ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975 NDA GlaxoSmithKline LLC 0173-0869 N 0173-0869-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approval Date:Dec 18, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 18, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:May 10, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:May 21, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Moodys
Chubb
Colorcon
Deloitte
Johnson and Johnson
Federal Trade Commission
McKesson
Merck

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