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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

No clinical trials found on ClinicalTrials.gov for this drug

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)

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