Viewing data from:

BLUJEPA

NDA

GEPOTIDACIN MESYLATE | N218230 | GLAXOSMITHKLINE LLC

1 strength4 unique patents3 unique exclusivities

Patent Timeline

4 unique patents, 3 exclusivities by expiration date

Active (4)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Feb. 12, 2029

Aug. 20, 2035

Aug. 20, 2035

Dec. 13, 2042

I-978

Dec. 11, 2028

NCE

Mar. 25, 2030

GAIN

Mar. 25, 2035

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

5 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)NCT04020341	Phase 3	Completed	GlaxoSmithKline	1,531	2019-10-17 → 2022-11-30
Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects NCT04079790	Phase 1	Completed	GlaxoSmithKline	34	2019-09-04 → 2019-11-25
To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.NCT02853435	Phase 1	Completed	GlaxoSmithKline	48	2016-08-04 → 2017-10-17
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)NCT04187144	Phase 3	Completed	GlaxoSmithKline	1,606	2020-04-23 → 2022-12-01
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea NCT04010539	Phase 3	Completed	GlaxoSmithKline	628	2019-10-21 → 2023-10-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$91.27

per ea

Lowest NADAC/Unit

$91.27

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173092245BLUJEPA 750 MG TABLET	$91.27	EA	Brand	—	2026-10-21
00173092238BLUJEPA 750 MG TABLET	$91.27	EA	Brand	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1394.24

Highest Price

$1871.36

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00173-0922-45BLUJEPA 750MG TAB	$1394.24	Big4	GlaxoSmithKline	07/31/2027
00173-0922-45BLUJEPA 750MG TAB	$1871.36	FSS	GlaxoSmithKline	07/31/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 12, 2025	SUPPL -1	View Letter (PDF)
Mar 27, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 750MG BASE

RLD

4 patents3 exclusivities▴

TABLET;ORAL | Approved: Mar 25, 2025

Patents (4) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8389524	Feb 12, 2029	—	Yes	Yes	—
10702521	Aug 20, 2035	—	—	—	—
11229646	Aug 20, 2035	—	—	—	—
12528809	Dec 13, 2042	—	Yes	Yes	—

Exclusivities (3)

Code	Date	Status
GAIN	Mar 25, 2035	Active
I-978	Dec 11, 2028	Active
NCE	Mar 25, 2030	Active