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ANORO ELLIPTA Drug Patent Profile

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Which patents cover Anoro Ellipta, and when can generic versions of Anoro Ellipta launch?

Anoro Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are twelve patents protecting this drug.

This drug has three hundred and twenty-nine patent family members in forty-eight countries.

The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Anoro Ellipta

Anoro Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 29, 2030. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for ANORO ELLIPTA

International Patents:	329
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	47
Patent Applications:	335
Drug Prices:	Drug price information for ANORO ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANORO ELLIPTA
What excipients (inactive ingredients) are in ANORO ELLIPTA?	ANORO ELLIPTA excipients list
DailyMed Link:	ANORO ELLIPTA at DailyMed

Drug patent expirations by year for ANORO ELLIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ANORO ELLIPTA

Generic Entry Date for ANORO ELLIPTA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 203975 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.

Recent Clinical Trials for ANORO ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Baylor Research Institute	Phase 4
Chiesi Farmaceutici S.p.A.	Phase 4
Luis Puente Maestu	Phase 4

See all ANORO ELLIPTA clinical trials

Pharmacology for ANORO ELLIPTA

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ANORO ELLIPTA

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for ANORO ELLIPTA

ANORO ELLIPTA is protected by twelve US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ANORO ELLIPTA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ANORO ELLIPTA

Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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.

Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Manifold for use in medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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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;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ANORO ELLIPTA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ANORO ELLIPTA

When does loss-of-exclusivity occur for ANORO ELLIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 10326798
Estimated Expiration: ⤷ Sign Up

Patent: 14204459
Estimated Expiration: ⤷ Sign Up

Patent: 16262698
Estimated Expiration: ⤷ Sign Up

Patent: 17238392
Estimated Expiration: ⤷ Sign Up

Patent: 18282427
Estimated Expiration: ⤷ Sign Up

Patent: 21204302
Estimated Expiration: ⤷ Sign Up

Patent: 23219901
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2012012925
Estimated Expiration: ⤷ Sign Up

Patent: 2018069147
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 81487
Estimated Expiration: ⤷ Sign Up

Patent: 18345
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 12001432
Estimated Expiration: ⤷ Sign Up

China

Patent: 2724974
Estimated Expiration: ⤷ Sign Up

Patent: 7412229
Estimated Expiration: ⤷ Sign Up

Patent: 8778288
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 41613
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 120265
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0180312
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 20058
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 06844
Estimated Expiration: ⤷ Sign Up

Dominican Republic

Patent: 012000148
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 3839
Estimated Expiration: ⤷ Sign Up

Patent: 1290266
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 06844
Estimated Expiration: ⤷ Sign Up

Patent: 35707
Estimated Expiration: ⤷ Sign Up

Patent: 32892
Estimated Expiration: ⤷ Sign Up

France

Patent: C1022
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 49407
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 36216
Estimated Expiration: ⤷ Sign Up

Patent: 800027
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 9893
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 16631
Estimated Expiration: ⤷ Sign Up

Patent: 13512270
Estimated Expiration: ⤷ Sign Up

Patent: 19509315
Estimated Expiration: ⤷ Sign Up

Lithuania

Patent: 506844
Estimated Expiration: ⤷ Sign Up

Patent: 2018011
Estimated Expiration: ⤷ Sign Up

Patent: 06844
Estimated Expiration: ⤷ Sign Up

Luxembourg

Patent: 0077
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 4864
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 1290
Estimated Expiration: ⤷ Sign Up

Patent: 12006310
Estimated Expiration: ⤷ Sign Up

Montenegro

Patent: 965
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 853
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 0026
Estimated Expiration: ⤷ Sign Up

Norway

Patent: 06844
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 130042
Estimated Expiration: ⤷ Sign Up

Patent: 170915
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 06844
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 06844
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 18131440
Estimated Expiration: ⤷ Sign Up

Serbia

Patent: 848
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 1087
Estimated Expiration: ⤷ Sign Up

Patent: 201407864U
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 06844
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1203890
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1742140
Estimated Expiration: ⤷ Sign Up

Patent: 1830728
Estimated Expiration: ⤷ Sign Up

Patent: 120092163
Estimated Expiration: ⤷ Sign Up

Patent: 170061719
Estimated Expiration: ⤷ Sign Up

Patent: 180128937
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 59330
Estimated Expiration: ⤷ Sign Up

Turkey

Patent: 1802921
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 6775
Estimated Expiration: ⤷ Sign Up

United Kingdom

Patent: 21075
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ANORO ELLIPTA around the world.

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Country	Patent Number	Title	Estimated Expiration
Canada	2458534	DERIVES DE PHENETHANOLAMINE DESTINES AU TRAITEMENT DE MALADIES RESPIRATOIRES (PHENETHANOLAMINE DERIVATIVES FOR TREATMENT OF RESPIRATORY DISEASES)	⤷ Sign Up
Spain	2359244		⤷ Sign Up
Hong Kong	1101722	COUNTER FOR USE WITH A MEDICAMENT DISPENSER	⤷ Sign Up
Portugal	1907037		⤷ Sign Up
Poland	289264		⤷ Sign Up
France	2660550		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ANORO ELLIPTA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	300694	Netherlands	⤷ Sign Up	PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
2506844	CA 2018 00023	Denmark	⤷ Sign Up	PRODUCT NAME: FARMACEUTISK KOMBINATIONSPRODUKT OMFATTENDE ET FARMACEUTISK ACCEPTABELT SALT AF UMECLIDINIUM (F.EKS. UMECLIDINIUMBROMID), VILANTEROL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF (F.EKS. VILANTEROLTRIFENATAT) OG FLUTICASONFUROAT; REG. NO/DATE: EU/1/17/1236 20171117
1740177	1490060-9	Sweden	⤷ Sign Up	MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
2506844	132018000000341	Italy	⤷ Sign Up	PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
2506844	C20180017 00244	Estonia	⤷ Sign Up	PRODUCT NAME: FLUTIKASOONFUROAAT/UMEKLIDIINIUM/VILANTEROOL;REG NO/DATE: EU/1/17/1236 17.11.2017
1740177	58/2014	Austria	⤷ Sign Up	PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922 (MITTEILUNG) 20140430
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

Summary for ANORO ELLIPTA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ANORO ELLIPTA

Recent Clinical Trials for ANORO ELLIPTA

Pharmacology for ANORO ELLIPTA

Anatomical Therapeutic Chemical (ATC) Classes for ANORO ELLIPTA

Patents protecting ANORO ELLIPTA

When does loss-of-exclusivity occur for ANORO ELLIPTA?

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ANORO ELLIPTA