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MOBAN

NDA

MOLINDONE HYDROCHLORIDE | N017111 | CHARTWELL RX SCIENCES LLC

8 strengths0 unique patents0 unique exclusivities

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
CorePharma, LLC - Citizen Petition FDA-2013-P-0631 · 5 docket documents CorePharma, LLC filed this citizen petition requesting that the FDA determine whether Moban Tablets (NDA 017111), manufactured by Endo Pharmaceuticals Inc. and discontinued in May 2010, was withdrawn from the market for reasons other than safety or effectiveness, to enable CorePharma to pursue appro	505(q)	2013-06-06	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Open-Label, Extension Study to 810P202 NCT01416064	Phase 2	Completed	Supernus Pharmaceuticals, Inc.	78	2011-09 → 2013-02
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems NCT00626236	Phase 2	Completed	Supernus Pharmaceuticals, Inc.	78	2008-10-21 → 2009-09-23
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)NCT00053703	Phase 4	Completed	University of North Carolina, Chapel Hill	116	2002-02 → 2007-05

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

API Supply Chain2 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

PH HEALTH LTDMOLINDONE HYDROCHLORIDE

DMF 194482006

MATRIX PHARMACORP PRIVATE LTDMOLINDONE HYDROCHLORIDE USP

DMF 207752007

CILAG AGInactiveMOLINDONE HYDROCHLORIDE

DMF 79921989

BIOREX RESEARCH DEVELOPMENT COInactiveMOLINDONE HYDROCHLORIDE

DMF 102611993

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2025	SUPPL -69	View Letter (PDF)
Mar 2, 2017	SUPPL -68	View Letter (PDF)
Dec 6, 2010	SUPPL -67	View Letter (PDF)
Jul 23, 2009	SUPPL -66	View Letter (PDF)
Aug 19, 2008	SUPPL -63	View Letter (PDF)
Mar 17, 2008	SUPPL -62	View Letter (PDF)
Apr 9, 2003	SUPPL -55	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

Sort:

#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾