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ANORO ELLIPTA Drug Profile
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» See Plans and PricingWhen do Anoro Ellipta patents expire, and what generic alternatives are available?
Anoro Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are fourteen patents protecting this drug.
This drug has three hundred and thirty-four patent family members in forty-six countries.
The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.
US ANDA Litigation and Generic Entry Outlook for Anoro Ellipta
Anoro 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.
Indicators of Generic Entry
Summary for ANORO ELLIPTA
| International Patents: | 334 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 34 |
| Drug Prices: | Drug price information for ANORO ELLIPTA |
| DailyMed Link: | ANORO ELLIPTA at DailyMed |
Generic Entry Opportunity Date for ANORO ELLIPTA
Generic Entry Date for ANORO 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 ANORO ELLIPTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Parexel | Phase 2 |
| AstraZeneca | Phase 2 |
| Parexel | Phase 4 |
Pharmacology for ANORO ELLIPTA
| Drug Class | Anticholinergic beta2-Adrenergic Agonist |
| Mechanism of Action | Cholinergic Antagonists Adrenergic beta2-Agonists |
Synonyms for ANORO ELLIPTA
| Ellipta |
| GSK 573719 |
| S900006130 |
| Umeclidinium and vilanterol |
| Umeclidinium bromide / vilanterol |
| Umeclidinium bromide and vilanterol |
| Umeclidinium bromide mixture with vilanterol |
| Umeclidinium/vilanterol |
| Vilanterol / Umeclidinium |
US Patents and Regulatory Information for ANORO ELLIPTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 ANORO ELLIPTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ANORO ELLIPTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Argentina | 091595 | Start Trial |
| Hungary | E036216 | Start Trial |
| Spain | 2359244 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ANORO ELLIPTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1425001 | C01425001/01 | Switzerland | Start Trial | PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014 |
| 1425001 | C 2014 016 | Romania | Start 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 | 2014/024 | Ireland | Start Trial | PRODUCT NAME: VILANTEROL OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
