BREO ELLIPTA Drug Patent Profile
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When do Breo Ellipta patents expire, 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 fourteen 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
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Questions you can ask:
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Summary for BREO ELLIPTA
| International Patents: | 214 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 47 |
| Patent Applications: | 38 |
| 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 |
See drug prices for BREO ELLIPTA
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BREO ELLIPTA
*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 |
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 ⤷ 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 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Phenethanolamine derivatives for treatment of respiratory diseases
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
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
FDA Regulatory Exclusivity protecting BREO ELLIPTA
NEW STRENGTH
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-002 | Apr 30, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-003 | May 12, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 | 204275-002 | Apr 30, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-002 | Apr 30, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Cyprus
Patent: 21914
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 00950
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 00950
Patent: PRÉPARATIONS PHARMACEUTIQUES COMPRENANT 4-{(1R)-2-[(6-{2-[(2,6-DICHLOROBENZYL)OXY]ÉTHOXY}HEXYL)AMINO]-1-HYDROXYÉTHYL}-2-(HYDROXYMÉTHYL)-PHÉNOL (PHARMACEUTICAL FORMULATIONS COMPRISING 4-{(1 R)-2-[(6-{2-[(2,6-DICHLOROBENZYL)OXY]ETHOXY}HEXYL)AMINO]-1-HYDROXYETHYL}-2-(HYDROXYMETHYL)PHENOL)
Estimated Expiration: ⤷ Sign Up
Patent: 78169
Patent: PRÉPARATIONS PHARMACEUTIQUES COMPRENANT 4-{(1R)-2-[(6-{2-[(2,6-DICHLOROBENZYL)OXY]ÉTHOXY}HEXYL)AMINO]-1-HYDROXYÉTHYL}-2-(HYDROXYMÉTHYL)-PHÉNOL (PHARMACEUTICAL FORMULATIONS COMPRISING 4-{(1 R)-2-[(6-{2-[(2,6-DICHLOROBENZYL)OXY]ETHOXY}HEXYL)AMINO]-1-HYDROXYETHYL}-2-(HYDROXYMETHYL)PHENOL)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 45917
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 09985
Estimated Expiration: ⤷ Sign Up
Patent: 12518663
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 00950
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 00950
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 00950
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 00950
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 39352
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 BREO ELLIPTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Africa | 200300929 | 17.Beta.-carbothioate 17.Alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents. | ⤷ Sign Up |
| Australia | 2003244506 | PHARMACEUTICAL FORMULATION COMPRISING AN AQUEOUS SUSPENSION OF AN ANDROSTANE DERIVATIVE FOR THE TREATMENT OF INFLAMMATORY AND ALLERGIC CONDITIONS | ⤷ Sign Up |
| Colombia | 5310550 | NUEVO DERIVADO DE ANDROSTANO ANTIINFLAMATORIO, SU POLIMORFO, SUS FORMAS CRISTALINAS SOLVATADAS, COMPOSICIONES FARMACEUTIAS, PROCESO PARA PREPARARLO, INTERMEDIARIO | ⤷ Sign Up |
| South Africa | 200410295 | Medicament dispenser. | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BREO ELLIPTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1425001 | CR 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 20131114 |
| 1519731 | 92269 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 1305329 | C01305329/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007 |
| 1305329 | 326 | Finland | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.
ISSN: 2162-2639
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