BREVITAL SODIUM

NDA

METHOHEXITAL SODIUM | N011559 | PH HEALTH LTD

4 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

10 trials from ClinicalTrials.gov, 9 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ketamine Anesthesia in Electroconvulsive Therapy NCT01367119	N/A	Completed	Mayo Clinic	38	2011-05 → 2012-03
Methohexital v Propofol as General Anesthetic in Patients on ACEIs or ARBs NCT02624050	N/A	Completed	Milton S. Hershey Medical Center	51	2016-08-01 → 2018-01-31
Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression NCT01881763	Phase 4	Completed	Northwell Health	31	2010-06 → 2017-07
Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion NCT04187196	Phase 4	Completed	Wake Forest University Health Sciences	73	2020-04-29 → 2022-09-28
Comparison of Esketamine/Propofol and Methohexital Anesthesia for ECT NCT05655754	Phase 4	Completed	Medical University of Vienna	56	2022-11-01 → 2026-03-31
Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time NCT01567852	N/A	Completed	University of New Mexico	20	2011-08 → 2013-03
EEG Characteristics in ECT NCT04022226	Early Phase 1	Completed	University of New Mexico	11	2019-10-01 → 2020-10-01
Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression NCT01907217	Phase 4	Completed	St Patrick's Hospital, Ireland	138	2008-05 → 2015-04
Ketamine Anesthesia for Improvement of Depression in ECT NCT02752724	N/A	Completed	VA Puget Sound Health Care System	52	2016-03 → 2018-04-30
Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression NCT01309581	N/A	Terminated	James Murrough	3	2010-04 → 2010-10

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$54.62

Highest Price

$54.62

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42023-0105-01METHOHEXITAL NA 500MG/VIL INJ	$54.62	Big4	Endo USA, Inc.	09/30/2026
42023-0105-01METHOHEXITAL NA 500MG/VIL INJ	$54.62	FSS	Endo USA, Inc.	09/30/2026

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

API Supply Chain1 active DMF2 inactive

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

SOLARA ACTIVE PHARMA SCIENCES LTDMETHOHEXITAL USP

DMF 153532001

GANES CHEMICALS INC PENNSVILLE DIVInactiveMETHOHEXITAL

DMF 33961978

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTDInactiveMETHOHEXITAL, NON-STERILE, BULK DRUG

DMF 177002004

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 23, 2020	SUPPL -57	View Letter (PDF)
May 2, 2017	SUPPL -51	View Letter (PDF)
Jan 24, 2014	SUPPL -45	View Letter (PDF)
May 8, 2008	SUPPL -41	View Letter (PDF)
Jun 1, 2004	SUPPL -37	View Letter (PDF)
May 28, 2004	SUPPL -33	View Letter (PDF)
Jul 13, 2001	SUPPL -32	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 500MG/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 2.5GM/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 5GM/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 200MG/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 21, 2012