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ONFI

NDA

CLOBAZAM | N202067 | LUNDBECK PHARMACEUTICALS LLC

3 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
Citizen Petition from Ascend Laboratories LLC FDA-2018-P-2754 · 6 docket documents Ascend Laboratories LLC filed this petition requesting that the FDA determine whether ONFI (clobazam) tablets 5 mg (NDA 202067), held by Lundbeck Pharmaceutical LLC, was voluntarily withdrawn from sale for reasons of safety or efficacy, as the product now appears in the discontinued section of the O	505(q)	2018-07-18	Granted	Ascend Laboratories LLC

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

Clinical Trials

17 trials from ClinicalTrials.gov, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers NCT01011036	Phase 3	Completed	Insel Gruppe AG, University Hospital Bern	17	2009-12 → 2010-06
GABA Pathways in Autism Spectrum Disorder (ASD)NCT03678129	N/A	Completed	King's College London	109	2018-12-07 → 2025-06-27
A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol NCT02565108	Phase 2	Completed	Jazz Pharmaceuticals	20	2016-01-20 → 2016-07-21
Clobazam in Subjects With Lennox-Gastaut Syndrome NCT00162981	Phase 2	Completed	Lundbeck LLC	68	2005-10 → 2006-10
An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol NCT02564952	Phase 2	Completed	Jazz Pharmaceuticals	18	2016-03-11 → 2017-06-07
Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome NCT01160770	Phase 3	Completed	Lundbeck LLC	267	2005-12 → 2012-02
Use of Clobazam for Epilepsy and Anxiety NCT03371836	Phase 4	Completed	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	20	2017-10-01 → 2019-12-31
GABAergic Modulation in Pain Transmission in Human: Effect of the GABAA Agonist Clobazam on Peripheral and Central Sensitisation NCT01291316	Phase 1/2	Completed	University Hospital, Geneva	25	2010-04 → 2011-11
Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio)NCT01179828	Phase 3	Completed	Insel Gruppe AG, University Hospital Bern	150	2010-07 → 2015-12
Clobazam in Patients With Lennox-Gastaut Syndrome NCT00518713	Phase 3	Completed	Lundbeck LLC	238	2007-08 → 2010-04

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$59.93

per ea

Lowest NADAC/Unit

$29.92

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
67386031501ONFI 20 MG TABLET	$59.93	EA	Brand	$0.4793	2026-06-17
67386031401ONFI 10 MG TABLET	$29.92	EA	Brand	$0.2217	2026-06-17

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 (2 FSS, 2 Big4)

Lowest Price

$2254.52

Highest Price

$4997.62

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
67386-0314-01ONFI 10MG TAB	$2498.82	FSS	Lundbeck LLC	09/30/2026
67386-0314-01ONFI 10MG TAB	$2254.52	Big4	Lundbeck LLC	09/30/2026
67386-0315-01ONFI 20MG TAB	$4997.62	FSS	Lundbeck LLC	09/30/2026
67386-0315-01ONFI 20MG TAB	$4508.02	Big4	Lundbeck LLC	09/30/2026

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

Medicare Part D Spending

CMS annual spending data for Onfi (2024)

Total Spending

$31.4M

Total Claims

9,712

Beneficiaries

1,143

Avg Cost/Unit

$37.61

Spending Trend

$48.1M(2019)→$32.3M(2020)→$30.0M(2021)→$29.8M(2022)→$31.5M(2023)→$31.4M(2024)

YoY Change:+3.2%

5yr CAGR:+7.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs1 inactive

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

EUROAPI GERMANY GMBHCLOBAZAM

DMF 183402005

FIS FABBRICA ITALIANA SINTETICI SPACLOBAZAM

DMF 247282011

CAMBREX PROFARMACO MILANO SRLCLOBAZAM

DMF 290612015

PIRAMAL PHARMA LTDCLOBAZAM

DMF 291642015

HONOUR LAB LTDCLOBAZAM

DMF 293512015

CENTAUR PHARMACEUTICALS PRIVATE LTDCLOBAZAM USP

DMF 294072015

RAKS PHARMA PVT LTDCLOBAZAM

DMF 305402016

MSN LIFE SCIENCES PRIVATE LTDCLOBAZAM USP

DMF 308752016

MICRO LABS LTDCLOBAZAM

DMF 320592017

FIS FABBRICA ITALIANA SINTETICI SPAInactiveCLOBAZAM

DMF 180802005

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Mar 13, 2024	SUPPL -8	View Letter (PDF)
Jan 17, 2023	SUPPL -7	View Letter (PDF)
Feb 9, 2021	SUPPL -6	View Letter (PDF)
Jun 20, 2018	SUPPL -5	View Letter (PDF)
Dec 22, 2016	SUPPL -4	View Letter (PDF)
Dec 11, 2014	SUPPL -3	View Letter (PDF)
Nov 26, 2013	SUPPL -2	View Letter (PDF)
Oct 25, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

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

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 21, 2011

No patent or exclusivity listings for this strength.

#002 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 21, 2011

#003 — 20MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 21, 2011