Viewing data from:

EXXUA

NDA

GEPIRONE HYDROCHLORIDE | N021164 | FABRE KRAMER PHARMACEUTICALS INC

4 strengths1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

Today

7538116

Sep. 2, 2030

NCE

Sep. 22, 2028

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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Gepirone vs Placebo in Treatment of Cocaine Dependence - 3 NCT00000189	Phase 2	Completed	University of Pennsylvania	41	1990-01 → 1991-02

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$57.53

per ea

Lowest NADAC/Unit

$56.55

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
23594015032EXXUA ER 18.2 MG TAB (TITRATN)	$57.53	EA	Brand	—	2026-08-19
23594015230EXXUA ER 54.5 MG TABLET	$56.55	EA	Brand	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$1363.85

Highest Price

$1454.77

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
23594-0151-30EXXUA 36.3MG TAB,SA	$1363.85	FSS	Neos Therapeutics Brands	01/31/2027
23594-0150-32EXXUA 18.2MG TAB,SA STARTER PACK,32	$1454.77	FSS	Neos Therapeutics Brands	01/31/2027
23594-0152-30EXXUA 54.5MG TAB,SA	$1363.85	FSS	Neos Therapeutics Brands	01/31/2027
23594-0153-30EXXUA 72.6MG TAB,SA	$1363.85	FSS	Neos Therapeutics Brands	01/31/2027

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

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

ERREGIERRE SPAGEPIRONE HYDROCHLORIDE

DMF 142971999

ERYTHRO PHARMA PRIVATE LTDGEPIRONE HYDROCHLORIDE AMIDE INTERMEDIATE

DMF 403062024

MAITHRI LABORATORIES PRIVATE LTDGEPIRONE HYDROCHLORIDE

DMF 415142025

NEW HORIZON PHARMA US INCGEPIRONE HYDROCHLORIDE

DMF 433492025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 9, 2025	SUPPL -1	View Letter (PDF)
Sep 25, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 18.2MG BASE

RLD

1 patent1 exclusivity▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 22, 2023

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7538116	Sep 2, 2030	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Sep 22, 2028	Active

#002 — EQ 36.3MG BASE

RLD

1 patent1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 22, 2023

#003 — EQ 54.5MG BASE

RLD

1 patent1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 22, 2023

#004 — EQ 72.6MG BASE

RLD

1 patent1 exclusivity▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 22, 2023