Viewing data from:

CEREBYX

NDA

FOSPHENYTOIN SODIUM | N020450 | PARKE DAVIS DIV WARNER LAMBERT CO

1 strength0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

7 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin NCT00908453	Phase 3	Completed	Nobelpharma	40	2009-05 → 2010-02
Established Status Epilepticus Treatment Trial NCT01960075	Phase 3	Completed	University of Virginia	478	2015-10 → 2019-05
Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus NCT01870024	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris	434	2013-06-26 → 2018-02-23
Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures NCT01458522	Phase 2	Completed	Aatif Husain	74	2012-05 → 2015-07
IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures NCT00510783	Phase 4	Completed	Emory University	158	2007-07 → 2008-12
A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide NCT01110187	N/A	Terminated	University of Alabama at Birmingham	11	2010-05 → 2012-05
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders NCT00801931	Phase 1/2	Terminated	Columbia University	1	2007-09-06 → 2009-05-05

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$54.42

Highest Price

$201.38

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-6001-21CEREBYX 500MGPE/10ML	$201.38	FSS	Pfizer Inc.	06/30/2029
00069-6001-21CEREBYX 500MGPE/10ML	$201.38	Big4	Pfizer Inc.	06/30/2029
00069-6001-25CEREBYX 100MGPE/2ML	$54.42	Big4	Pfizer Inc.	06/30/2029
00069-6001-25CEREBYX 100MGPE/2ML	$94.92	FSS	Pfizer Inc.	06/30/2029

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

Medicare Part D Spending

CMS annual spending data for Cerebyx (2024)

Total Spending

$45K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$12.40

Spending Trend

$9K(2019)→$28K(2020)→$62K(2021)→$79K(2022)→$51K(2023)→$45K(2024)

YoY Change:+7.6%

5yr CAGR:+3.0%

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

API Supply Chain5 active DMFs5 inactive

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

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTDFOSPHENYTOIN SODIUM USP

DMF 173332004

SUN PHARMACEUTICAL INDUSTRIES LTDFOSPHENYTOIN SODIUM USP

DMF 194552006

GUANG'AN KINGDAY PHARMA AND CHEM CO LTDFOSPHENYTOIN SODIUM USP

DMF 328162018

GLAND PHARMA LTDFOSPHENYTOIN SODIUM

DMF 337562019

CHEMWERTH INCFOSPHENYTOIN SODIUM USP

DMF 375652023

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveFOSPHENYTOIN SODIUM API

DMF 168992003

DIVIS LABORATORIES LTDInactiveFOSPHENYTOIN SODIUM USP

DMF 188062005

CILAG AGInactiveFOSPHENYTOIN SODIUM DRUG SUBSTANCE (ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 189542005

DR REDDYS LABORATORIES LTDInactiveFOSPHENYTOIN SODIUM

DMF 205112007

TRIFARMA SPAInactiveFOSPHENYTOIN SODIUM

DMF 209702007

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

Approval Letters

19 letters from Drugs@FDA

Date	Submission	Document
Dec 6, 2021	SUPPL -45	View Letter (PDF)
Feb 17, 2021	SUPPL -42	View Letter (PDF)
Jan 29, 2020	SUPPL -40	View Letter (PDF)
Jul 15, 2019	SUPPL -39	View Letter (PDF)
Nov 6, 2017	SUPPL -38	View Letter (PDF)
Nov 6, 2017	SUPPL -37	View Letter (PDF)
Mar 14, 2017	SUPPL -36	View Letter (PDF)
Mar 2, 2017	SUPPL -3	View Letter (PDF)
Nov 8, 2016	SUPPL -33	View Letter (PDF)
Mar 4, 2016	SUPPL -29	View Letter (PDF)
Jun 10, 2015	SUPPL -28	View Letter (PDF)
Jun 17, 2014	SUPPL -25	View Letter (PDF)
Jan 7, 2014	SUPPL -23	View Letter (PDF)
Oct 24, 2013	SUPPL -24	View Letter (PDF)
Mar 8, 2013	SUPPL -20	View Letter (PDF)
Nov 17, 2011	SUPPL -19	View Letter (PDF)
Nov 17, 2011	SUPPL -16	View Letter (PDF)
Nov 17, 2011	SUPPL -8	View Letter (PDF)
Nov 17, 2011	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG PHENYTOIN NA/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 5, 1996

No patent or exclusivity listings for this strength.