DrugPatentWatch Database Preview
BREO ELLIPTA Drug 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 fourteen patents protecting this drug.
This drug has three hundred and sixty-nine patent family members in forty-two countries.
The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.
Summary for BREO ELLIPTA
| International Patents: | 369 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 26 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BREO ELLIPTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BREO ELLIPTA |
| DailyMed Link: | BREO ELLIPTA at DailyMed |
Generic Entry Opportunity 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.
Pharmacology for BREO ELLIPTA
| Drug Class | beta2-Adrenergic Agonist Corticosteroid |
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for BREO ELLIPTA
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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 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for BREO ELLIPTA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,531,528 | Formulation containing anti-inflammatory androstane derivatives | ➤ Sign Up |
| 7,132,532 | Compounds useful in the manufacture of an anti-inflammatory androstane derivative | ➤ Sign Up |
| 7,144,845 | Compounds useful in the manufacture of an anti-inflammatory androstane derivative | ➤ Sign Up |
| 6,750,210 | Formulation containing novel anti-inflammatory androstane derivative | ➤ Sign Up |
| 7,498,321 | 17.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents | ➤ Sign Up |
| 6,858,593 | Anti-inflammatory androstane derivative compositions | ➤ Sign Up |
| 7,541,350 | Formulation containing anti-inflammatory androstane derivative | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for BREO ELLIPTA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Spain | 2561421 | ➤ Sign Up |
| South Africa | 200401990 | ➤ Sign Up |
| South Korea | 20060129057 | ➤ Sign Up |
| European Patent Office | 2348032 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 03066032 | ➤ Sign Up |
| Australia | 2005274296 | ➤ Sign Up |
| Canada | 2493078 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for BREO ELLIPTA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 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 |
| C0028 | France | ➤ Sign Up | PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI,EN PARTICULIER LE TRIFENATATE DE VILANTEROL.; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113 |
| 00664 | 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 |
| 6 | Finland | ➤ Sign Up | |
| 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 |
| 439 | Luxembourg | ➤ Sign Up | PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI |
| 2008000029 | Germany | ➤ Sign Up | PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
