Viewing data from:

BREXAFEMME

NDA

IBREXAFUNGERP CITRATE | N214900 | GLAXOSMITHKLINE LLC

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

Aug. 28, 2030

Jan. 19, 2035

Jan. 19, 2035

Jan. 19, 2035

Jun. 10, 2039

NCE

Jun. 1, 2026

GAIN

Jun. 1, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jul 28, 2026	SUPPL -4	View Letter (PDF)
Nov 4, 2025	SUPPL -3	View Letter (PDF)
Dec 1, 2022	SUPPL -2	View Letter (PDF)
Jun 16, 2022	SUPPL -1	View Letter (PDF)
Jun 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 150MG BASE

RLD

6 patents2 exclusivities▴

TABLET;ORAL | Approved: Jun 1, 2021

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8188085	Aug 28, 2030	—	Yes	Yes		—
10174074	Jan 19, 2035	—	Yes	Yes	—	—
10370406	Jan 19, 2035	—	—	—		—
10927142	Jan 19, 2035	—	Yes	—	—	—
11534433	Jun 10, 2039	—	—	—		—
11534433	Jun 10, 2039	—	—	—		—

Exclusivities (2)

Code	Date	Status
GAIN	Jun 1, 2031	Active
NCE	Jun 1, 2026	Expired

Change History (1)

Recent changes detected for this application.

ADDED10/22/2026

BREXAFEMME (ibrexafungerp citrate) gained New Chemical Entity exclusivity expiring Jun 2031.

New: BREXAFEMME (IBREXAFUNGERP CITRATE) — exclusivity NCE*GAIN exp 06/01/2031