DrugPatentWatch Database Preview
BREO ELLIPTA Drug Profile
Which patents cover Breo Ellipta, and what generic alternatives are available?
Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are fourteen patents protecting this drug.
The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-eight 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
| 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
| 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 | 204275-002 | Apr 30, 2015 | 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 | Y | ➤ 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 | 204275-001 | May 10, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | RX | Yes | Yes | ➤ 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 | ||||
| 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 | ➤ Sign Up | ➤ Sign Up |
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-002 | Apr 30, 2015 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for BREO ELLIPTA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0514346 | ➤ Sign Up |
| Brazil | 0212455 | ➤ Sign Up |
| Denmark | 1786498 | ➤ Sign Up |
| Australia | 2004262907 | ➤ Sign Up |
| Australia | 2003236835 | ➤ Sign Up |
| European Patent Office | 1775305 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for BREO ELLIPTA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0343 | Netherlands | ➤ Sign Up | 300343, 20210803, EXPIRES: 20230110 |
| 2014019 | Lithuania | ➤ Sign Up | PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113 |
| 0140013 00103 | Estonia | ➤ Sign Up | PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013 |
| 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 |
| 1425001/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014 |
| 269 | Luxembourg | ➤ Sign Up | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
