TRELEGY ELLIPTA Drug Patent Profile
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Which patents cover Trelegy Ellipta, and what generic alternatives are available?
Trelegy 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 TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.
DrugPatentWatch® Generic Entry Outlook for Trelegy Ellipta
Trelegy 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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Questions you can ask:
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Summary for TRELEGY ELLIPTA
International Patents: | 329 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 4 |
Drug Prices: | Drug price information for TRELEGY ELLIPTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRELEGY ELLIPTA |
What excipients (inactive ingredients) are in TRELEGY ELLIPTA? | TRELEGY ELLIPTA excipients list |
DailyMed Link: | TRELEGY ELLIPTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRELEGY ELLIPTA
Generic Entry Date for TRELEGY ELLIPTA*:
Constraining patent/regulatory exclusivity:
NDA:
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 TRELEGY ELLIPTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Baylor Research Institute | Phase 4 |
GlaxoSmithKline | Phase 4 |
Pharmacology for TRELEGY ELLIPTA
US Patents and Regulatory Information for TRELEGY ELLIPTA
TRELEGY ELLIPTA is protected by thirteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRELEGY 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 TRELEGY 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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) COMPRISING THE ONCE PER DAY ADMINISTRATION OF TRELEGY ELLIPTA, 100 MCG FLUTICASONE FUROATE/62.5 MCG UMECLIDINIUM/25 MCG VILANTEROL
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
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: METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA INHALATION
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
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
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
Expired US Patents for TRELEGY ELLIPTA
International Patents for TRELEGY ELLIPTA
When does loss-of-exclusivity occur for TRELEGY ELLIPTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 10326798
Patent: Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Estimated Expiration: ⤷ Sign Up
Patent: 14204459
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Patent: 16262698
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Patent: 17238392
Patent: Mannose-derived antagonists of FimH useful for treating disease
Estimated Expiration: ⤷ Sign Up
Patent: 18282427
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Patent: 21204302
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Patent: 23219901
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012012925
Patent: produto de combinação farmacêutico, inalador de pó seco, e, uso de um produto
Estimated Expiration: ⤷ Sign Up
Patent: 2018069147
Patent: composto da fórmula iii, composição farmacêutica, método de inibição da função de fimh e método de tratamento de uma doença mediada por fimh
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 81487
Patent: COMBINAISONS D'UN ANTAGONISTE DE RECEPTEUR MUSCARINIQUE ET D'UN AGONISTE DU RECEPTEUR BETA-2 ADRENERGIQUE (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷ Sign Up
Patent: 18345
Patent: ANTAGONISTES DERIVES DU MANNOSE DE FIMH UTILES POUR LE TRAITEMENT D'UNE MALADIE (MANNOSE-DERIVED ANTAGONISTS OF FIMH USEFUL FOR TREATING DISEASE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 12001432
Patent: Producto de combinacion farmacéutica que comprende bromuro de 4-[hidroxi-(difenil)-metil]-1-{2-[(fenil-metil)-oxi]-etil}-1-azonia-biciclo-[2.2.2]-octano y trifenil-acetato de 4-{(1r)-2-[(6-{2-[(2,6-dicloro-bencil)-oxi]-etoxi}-hexil)-amino]-1-hidroxi-etil}-2-(hidroxi-metil)-fenol; y su uso para tratar enfermedades respiratorias.
Estimated Expiration: ⤷ Sign Up
China
Patent: 2724974
Patent: Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Estimated Expiration: ⤷ Sign Up
Patent: 7412229
Patent: 毒蕈碱受体拮抗剂和β‑2肾上腺素受体激动剂的组合 (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷ Sign Up
Patent: 8778288
Patent: 可用于治疗疾病的FimH的甘露糖衍生的拮抗剂 (Mannose-derived antagonists of FimH useful for treating disease)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 41613
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARÍNICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA 2
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 120265
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARÍNICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2
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
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARINICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 3839
Patent: КОМБИНАЦИИ АНТАГОНИСТА МУСКАРИНОВЫХ РЕЦЕПТОРОВ И АГОНИСТА БЕТА-2-АДРЕНОРЕЦЕПТОРОВ (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷ Sign Up
Patent: 1290266
Patent: КОМБИНАЦИИ АНТАГОНИСТА МУСКАРИНОВЫХ РЕЦЕПТОРОВ И АГОНИСТА БЕТА-2-АДРЕНОРЕЦЕПТОРОВ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 06844
Patent: Combinaisons d'un antagoniste de récepteur muscarinique et d'un agoniste du récepteur bêta-2 adrénergique (Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist)
Estimated Expiration: ⤷ Sign Up
Patent: 35707
Patent: COMBINAISONS D'UN ANTAGONISTE DE RÉCEPTEUR MUSCARINIQUE ET D'UN AGONISTE DU RÉCEPTEUR BÊTA-2 ADRÉNERGIQUE (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷ Sign Up
Patent: 32892
Patent: ANTAGONISTES DÉRIVÉS DU MANNOSE DE FIMH UTILES POUR LE TRAITEMENT D'UNE MALADIE (MANNOSE-DERIVED ANTAGONISTS OF FIMH USEFUL FOR TREATING DISEASE)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1022
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 49407
Patent: 毒蕈碱受體拮抗劑和β-2腎上腺素受體激動劑的組合 (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 36216
Estimated Expiration: ⤷ Sign Up
Patent: 800027
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9893
Patent: שילובים של אנטגוניסט לקולטן מוסקריני ואגוניסט לקולטן בתא-2-אדרנו (Combinations of a muscarinic receptor antagonist and a beta-2 adrenorecptor agonist)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 16631
Estimated Expiration: ⤷ Sign Up
Patent: 13512270
Estimated Expiration: ⤷ Sign Up
Patent: 19509315
Patent: 疾患の処置に有用なFimHのマンノース由来アンタゴニスト
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
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 1290
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARÍNICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2. (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST.)
Estimated Expiration: ⤷ Sign Up
Patent: 12006310
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARINICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2. (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 965
Patent: KOMBINACIJE ANTAGONISTA MUSKARINSKOG RECEPTORA I AGONISTA ВЕТА - 2 ADRENORECEPTORA (Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 853
Patent: تركيبة مضاد استقبال المسكارينية ومحضر استقبال بتي ـ 2 الأدرينالية
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0026
Patent: Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 06844
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 130042
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARINICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2
Estimated Expiration: ⤷ Sign Up
Patent: 170915
Patent: COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARINICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 06844
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 06844
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 18131440
Patent: Антагонисты FimH, являющиеся производными маннозы, пригодные для лечения заболевания
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 848
Patent: KOMBINACIJE ANTAGONISTA MUSKARINSKOG RECEPTORA I AGONISTA BETA-2 ADRENORECEPTORA (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 1087
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Patent: 201407864U
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 06844
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1203890
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1742140
Estimated Expiration: ⤷ Sign Up
Patent: 1830728
Estimated Expiration: ⤷ Sign Up
Patent: 120092163
Patent: COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Patent: 170061719
Patent: 무스카린성 수용체 길항제 및 베타-2 아드레날린 수용체 효능제의 조합물 (- COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST)
Estimated Expiration: ⤷ Sign Up
Patent: 180128937
Patent: 질환을 치료하는데 유용한 FIMH의 만노스-유래 길항제
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 59330
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1802921
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 6775
Patent: КОМБІНАЦІЯ АНТАГОНІСТА МУСКАРИНОВОГО РЕЦЕПТОРА ТА АГОНІСТА БЕТА-2 АДРЕНОРЕЦЕПТОРА (COMBINATIONS OF MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONIST AND BETA 2 AGONIST)
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 TRELEGY ELLIPTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 333813 | ⤷ Sign Up | |
China | 102724974 | Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist | ⤷ Sign Up |
Norway | 342072 | ⤷ Sign Up | |
Brazil | 0312725 | ⤷ Sign Up | |
Slovenia | 1775305 | ⤷ Sign Up | |
Mexico | 2008001250 | DOSIFICADOR DE MEDICAMENTO. (MEDICAMENT DISPENSER.) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TRELEGY ELLIPTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1425001 | CA 2014 00021 | Denmark | ⤷ Sign Up | PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113 |
1519731 | 132013902182575 | Italy | ⤷ Sign Up | PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527 |
1740177 | 300694 | Netherlands | ⤷ Sign Up | PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430 |
1305329 | 300343 | Netherlands | ⤷ Sign Up | 300343, 20210803, EXPIRES: 20230110 |
1740177 | PA2014038 | Lithuania | ⤷ Sign Up | PRODUCT NAME: UMECLIDINIUM BROMIDIUM; REGISTRATION NO/DATE: EU/1/14/922 20140428 |
1425001 | C300664 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VILANTEROL, DAN WEL EEN ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TRIFENYLACETAATZOUT; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |