Product profile · United States

TRELEGY ELLIPTA

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IngredientFLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Application typeNDA

Application209482

Product001

Dosage formPOWDER

RouteINHALATION

Strength0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

Approval date2017-09-18

Marketing statusPrescription

Status event—

ApplicantGLAXOSMITHKLINE

Product source

Current GenericRadar decision

Year2030

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typePATENT

Anchor date2030-11-29

Patent anchor2030-11-29

Exclusivity anchor2018-12-18

Protection date2030-11-29

First Final ANDA—

Status event—

2030 DEEP_REVIEW. Whole-product combination claims US9750726 and US12396986 adopted as DS-equivalent, not TRUE_DS. Anchor 2030-11-29; device/PED tail US8746242 through 2031-04-11. US11090294 is COPD-only, not the whole-product anchor. No actual generic launch date asserted. Existing regulatory/generic facts retained; Paragraph IV filing is not Final ANDA approval.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
7488827	2027-12-18	DS/DP —	Y	N	TRUE_DS	—	—	—
7488827	2027-12-18	ORANGE_BOOK —	Y	N	TRUE_DS English description not available.	—	—	—
7488827	2027-12-18	DS/DP —	Y	N	TRUE_DS	—	—	—
8534281	2030-03-08	DP —	N	N	DP	—	—	—
8534281	2030-03-08	DP —	N	N	DP	—	—	—
8534281	2030-09-08	— —	N	N	DP	—	2030-09-08	—
8534281	2030-09-08	ORANGE_BOOK —	N	N	DP English description not available.	—	2030-09-08	—
8534281	2030-09-08	— —	N	N	DP	—	2030-09-08	—
8746242	2030-10-11	DP —	N	N	DP	—	—	—
8746242	2030-10-11	DP —	N	N	DP	—	—	—
RE51082	2030-10-11	DP —	N	N	UNREVIEWED Listing fact only. DS/DS-equivalent zero flags mean not promoted, not a negative scope conclusion. Expiry is source listed, effective legal end remains NULL. No judgment modification.	—	—	—
11090294	2030-11-29	U U-3202	N	N	U	—	—	—
11090294	2030-11-29	ORANGE_BOOK U-3202	N	N	U English description not available.	—	—	—
11090294	2030-11-29	U U-3202	N	N	U	—	—	—
12396986	2030-11-29	DP —	N	Y	DS_EQUIVALENT	—	—	—
12396986	2030-11-29	ORANGE_BOOK —	N	Y	DS_EQUIVALENT English description not available.	—	—	—
12396986	2030-11-29	DP —	N	Y	DS_EQUIVALENT	—	—	—
9750726	2030-11-29	DP —	N	Y	DS_EQUIVALENT	—	—	—
9750726	2030-11-29	ORANGE_BOOK —	N	Y	DS_EQUIVALENT English description not available.	—	—	—
9750726	2030-11-29	DP —	N	Y	DS_EQUIVALENT	—	—	—
8746242	2031-04-11	— —	N	N	DP	—	2031-04-11	—
8746242	2031-04-11	ORANGE_BOOK —	N	N	DP English description not available.	—	2031-04-11	—
8746242	2031-04-11	— —	N	N	DP	—	2031-04-11	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Source
NCE	2013-05-10	2018-05-10	NEW CHEMICAL ENTITY	Y	Y	2018-05-10	Source
NCE	2013-12-18	2018-12-18	NEW CHEMICAL ENTITY	Y	Y	2018-12-18	Source
I-775	2018-04-24	2021-04-24	REVISED INDICATION FOR FIXED-DOSE COMBINATION OF FLUTICASONE FUROATE, UMECLIDINIUM, AND VILANTEROL TO TREAT AIRFLOW OBSTRUCTION IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND TO REDUCE COPD EXACERBATIONS IN PTS WITH HISTORY OF EXACERBATIONS	N	N	—	Source

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
No final-approval records are linked to this product.

Decision evidence (9)

Type	Date	Role	Basis	Source
PATENT	2027-12-18	EARLIER_QUALIFYING_PATENT	Umeclidinium bromide and the underlying quaternary ammonium compound/salts; direct substance coverage.	Source
PATENT	2030-09-08	DEVICE_TAIL	Specific manifold, chimney, chamber and airflow structure. Device tail; not a substance or whole-scope GNR anchor.	Source
PATENT	2030-11-29	PARTIAL_SCOPE_RIGHT	COPD treatment method; listed only for 100/62.5/25. Asthma remains outside this indication-limited method; not a whole-product anchor.	Source
PATENT	2030-11-29	PATENT_ANCHOR	Claim 1 covers umeclidinium/acceptable anion about 62.5 mcg plus vilanterol/acceptable salt about 25 mcg as dry powders, once daily and simultaneous administration. Claim 12 expressly adds fluticasone furoate. Both strengths and COPD/asthma uses retain the combination. GNR operational DS-equivalent, not TRUE_DS.	Source
PATENT	2030-11-29	PATENT_ANCHOR	Claim 1 covers umeclidinium bromide about 62.5 mcg/dose plus vilanterol trifenatate about 25 mcg/dose as dry powders for once-daily simultaneous administration. Claim 8 adds fluticasone furoate without restricting its dose. Both approved Trelegy strengths retain this required combination for every approved use; specific device/excipients are not required by claim 1. GNR whole-product operational DS-equivalent, not TRUE_DS.	Source
PATENT	2031-04-11	DEVICE_TAIL	Specific medicament dispenser, dispensing mechanism, mouthpiece and cover mechanism. Device/PED tail.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	REVISED INDICATION FOR FIXED-DOSE COMBINATION OF FLUTICASONE FUROATE, UMECLIDINIUM, AND VILANTEROL TO TREAT AIRFLOW OBSTRUCTION IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND TO REDUCE COPD EXACERBATIONS IN PTS WITH HISTORY OF EXACERBATIONS	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	NEW CHEMICAL ENTITY	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	NEW CHEMICAL ENTITY	Source

Decision history

Current	Year	Status	Review	Anchor	Judged
Y	2030	DEEP_REVIEW	FINAL	2030-11-29	2026-10-22 03:08:19
N	2030	DEEP_REVIEW	FINAL	2030-11-29	2026-10-13 23:50:30

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.