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TRELEGY ELLIPTA Drug Profile
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» See Plans and PricingWhen do Trelegy Ellipta patents expire, and what generic alternatives are available?
Trelegy Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are nineteen patents protecting this drug.
This drug has five hundred and three patent family members in fifty-two countries.
The generic ingredient in TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.
US ANDA Litigation and Generic Entry Outlook for Trelegy Ellipta
Trelegy 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.
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 TRELEGY ELLIPTA
| International Patents: | 503 |
| US Patents: | 19 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRELEGY ELLIPTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRELEGY ELLIPTA |
| DailyMed Link: | TRELEGY ELLIPTA at DailyMed |
Generic Entry Opportunity Date for TRELEGY ELLIPTA
Generic Entry Date for TRELEGY 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.
Pharmacology for TRELEGY ELLIPTA
US Patents and Regulatory Information for TRELEGY ELLIPTA
International Patents for TRELEGY ELLIPTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100889426 | Start Trial |
| Japan | 2006502172 | Start Trial |
| European Patent Office | 2067784 | Start Trial |
| Singapore | 150524 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TRELEGY ELLIPTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1305329 | 08C0014 | France | Start Trial | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
| 1740177 | PA2014038,C1740177 | Lithuania | Start Trial | PRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428 |
| 1305329 | C 2008 007 | Romania | Start Trial | PRODUCT NAME: FUROATDE FLUTICAZONA SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/07/434/001; DATE OF NATIONAL AUTHORISATION: 20080111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/434/001, EU/1/07/434/002, EU/1/07/434/003; DATE OF FIRST AUTHORISATION IN EEA: 20080111 |
| 1425001 | 1490033-6 | Sweden | Start Trial | PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
