BREO ELLIPTA Drug Patent Profile
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Which patents cover Breo Ellipta, and when can generic versions of Breo Ellipta launch?
Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are seven patents protecting this drug.
This drug has two hundred and thirteen patent family members in thirty-two countries.
The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.
DrugPatentWatch® Generic Entry Outlook for Breo Ellipta
Breo 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 August 26, 2029. This may change due to patent challenges or generic licensing.
Annual sales in 2021 were $2.8bn, indicating a strong incentive for generic entry.
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
Summary for BREO ELLIPTA
International Patents: | 213 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 47 |
Patent Applications: | 49 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for BREO ELLIPTA |
Drug Sales Revenues: | Drug sales revenues for BREO ELLIPTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BREO ELLIPTA |
What excipients (inactive ingredients) are in BREO ELLIPTA? | BREO ELLIPTA excipients list |
DailyMed Link: | BREO ELLIPTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BREO ELLIPTA
Generic Entry Date for BREO 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 BREO 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 |
Pharmacology for BREO ELLIPTA
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for BREO ELLIPTA
US Patents and Regulatory Information for BREO ELLIPTA
BREO ELLIPTA is protected by seven US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BREO ELLIPTA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 BREO ELLIPTA
Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyet- hyl}-2-(hydroxymethyl) phenol
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Manifold for use in medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting BREO ELLIPTA
NEW STRENGTH
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-003 | May 12, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-002 | Apr 30, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-003 | May 12, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 BREO ELLIPTA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BREO ELLIPTA
When does loss-of-exclusivity occur for BREO ELLIPTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Croatia
Patent: 0191257
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 00950
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 00950
Estimated Expiration: ⤷ Try a Trial
Patent: 78169
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 45917
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 09985
Estimated Expiration: ⤷ Try a Trial
Patent: 12518663
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 00950
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 00950
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 00950
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 00950
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 39352
Estimated Expiration: ⤷ Try a Trial
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 BREO ELLIPTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2006528500 | ⤷ Try a Trial | |
Taiwan | I244486 | ⤷ Try a Trial | |
Colombia | 5310550 | NUEVO DERIVADO DE ANDROSTANO ANTIINFLAMATORIO, SU POLIMORFO, SUS FORMAS CRISTALINAS SOLVATADAS, COMPOSICIONES FARMACEUTIAS, PROCESO PARA PREPARARLO, INTERMEDIARIO | ⤷ Try a Trial |
Poland | 207531 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BREO ELLIPTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1425001 | C 2014 016 | Romania | ⤷ Try a Trial | PRODUCT NAME: VILANTEROL SAU O SARE SAU SOLVAT AL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF NATIONAL AUTHORISATION: 20131113; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF FIRST AUTHORISATION IN EEA: 20131113 |
1425001 | CR 2014 00021 | Denmark | ⤷ Try a Trial | PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131114 |
1305329 | 300343 | Netherlands | ⤷ Try a Trial | 300343, 20210803, EXPIRES: 20230110 |
1305329 | SZ 12/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |