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TRELEGY ELLIPTA Drug Profile
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When do Trelegy Ellipta patents expire, and when can generic versions of Trelegy Ellipta launch?
Trelegy Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are nineteen patents protecting this drug.
This drug has four hundred and ninety-four patent family members in fifty-one 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 10th, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 29th, 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.
Summary for TRELEGY ELLIPTA
| International Patents: | 494 |
| 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.
Recent Clinical Trials for TRELEGY ELLIPTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 4 |
Recent Litigation for TRELEGY ELLIPTA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-08 |
| GlaxoSmithKline Intellectual Property Management Limited v. Sandoz Inc. |
Pharmacology for TRELEGY ELLIPTA
Synonyms for TRELEGY ELLIPTA
| FF/UMEC/VI |
| Fluticasone furoate mixture with umeclidinium and vilanterol |
| Fluticasone furoate, umeclidinium and vilanterol |
| S900007500 |
US Patents and Regulatory Information for TRELEGY ELLIPTA
International Patents for TRELEGY ELLIPTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2013512270 | Start Trial |
| Spain | 2343315 | Start Trial |
| Portugal | 2348032 | Start Trial |
| Mexico | PA06009133 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TRELEGY ELLIPTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1305329 | 12/2008 | Austria | Start Trial | PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/07/434/001 - EU/1/07/434/003 20080111 |
| 2506844 | CA 2018 00023 | Denmark | Start Trial | PRODUCT NAME: FARMACEUTISK KOMBINATIONSPRODUKT OMFATTENDE ET FARMACEUTISK ACCEPTABELT SALT AF UMECLIDINIUM (F.EKS. UMECLIDINIUMBROMID), VILANTEROL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF (F.EKS. VILANTEROLTRIFENATAT) OG FLUTICASONFUROAT; REG. NO/DATE: EU/1/17/1236 20171117 |
| 1425001 | CR 2014 00021 | Denmark | Start Trial | PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131114 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
