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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 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FDA determine whether ONFI (clobazam) tablets 5 mg (NDA 202067), held by Lundbeck Pharmaceutical LLC, was voluntarily withdrawn from sale for reasons of safety or efficacy, as the product now appears in the discontinued section of the O	505(q)	2018-07-18	Withdrawn	Ascend Laboratories LLC

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Onfi (2023)

Total Spending

$31.5M

Total Claims

10,091

Beneficiaries

1,181

Avg Cost/Unit

$36.43

Spending Trend

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

YoY Change:+8.3%

5yr CAGR:+10.1%

Source: CMS Medicare Part D Spending by Drug (2023). 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

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