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SEZABY

NDA

PHENOBARBITAL SODIUM | N215910 | SUN PHARMACEUTICAL INDUSTRIES INC

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

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Today

11857683

Apr. 7, 2042

12636254

Apr. 7, 2042

ODE-414

Nov. 17, 2029

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Nivagen, Inc. v. Sun Pharmaceuticals Industries, Inc. et al 2:2024cv00036 2 patentsphenobarbital sodium	E.D. Tex.	2024-01-23	Terminated 2025-09-03	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Sidley Austin LLP FDA-2023-P-3078 · 74 docket documents Sidley Austin LLP, on behalf of Sun Pharma Advanced Research Company Limited, filed this citizen petition requesting that the FDA immediately recall unapproved phenobarbital sodium injection products marketed by Hikma Pharmaceuticals USA, Cameron Pharmaceuticals, Bryant Ranch Prepack, Nivagen Pharma	505(q)	2023-07-25	Open	Sidley Austin LLP

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

Clinical Trials

24 trials from ClinicalTrials.gov, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage NCT00009620	Phase 3	Completed	NICHD Neonatal Research Network	610	1993-02 → 1997-02
How to Treat Opiate Withdrawal in Neonates NCT02810782	Phase 3	Completed	University of Zurich	120	2001-06 → 2007-12
Phenobarbital for Acute Alcohol Withdrawal NCT01184417	N/A	Completed	Jonathan Rosenson	102	2009-01 → 2010-03
Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma NCT00002759	Phase 1	Completed	National Cancer Institute (NCI)	3	1996-06
A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine NCT00314340	Phase 4	Completed	University of California, Davis	12	2005-11 → 2008-04
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome NCT03670160	Phase 2	Completed	University of Tennessee Medical Center	25	2018-10-01 → 2020-05-31
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.NCT01224457	N/A	Completed	Yonsei University	52	2008-05 → 2010-05
Improving Outcomes in Neonatal Abstinence Syndrome NCT01958476	Phase 3	Completed	Tufts Medical Center	117	2013-09 → 2018-08-30
Efficacy of Intravenous Levetiracetam in Neonatal Seizures NCT01720667	Phase 1/2	Completed	Richard H. Haas	280	2013-03 → 2019-07-31
Childhood Convulsive Status Epilepticus Management In A Resource Limited Setting NCT03650270	Phase 3	Completed	University of Cape Town	198	2015-03-01 → 2018-03-01

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

VA Federal Supply Schedule

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

Lowest Price

$30.03

Highest Price

$123.53

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62756-0301-01SEZABY 100MG VIAL	$123.53	FSS	Sun Pharmaceutical Industries, Inc.	07/14/2026
62756-0301-01SEZABY 100MG VIAL	$30.03	Big4	Sun Pharmaceutical Industries, Inc.	07/14/2026

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

Medicare Part D Spending

CMS annual spending data for Phenobarbital Sodium (2024)

Total Spending

$95K

Total Claims

Beneficiaries

Avg Cost/Unit

$51.24

Spending Trend

$127K(2019)→$64K(2020)→$55K(2021)→$46K(2022)→$65K(2023)→$95K(2024)

YoY Change:+2.6%

5yr CAGR:+9.5%

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

API Supply Chain7 active DMFs2 inactive

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

SIEGFRIED USA LLCPHENOBARBITAL SODIUM USP

DMF 10491967

ALKALOIDA CHEMICAL CO ZRTPHENOBARBITAL USP

DMF 46421982

HARMAN FINOCHEM LTDPHENOBARBITAL USP

DMF 178232004

SHANDONG XINHUA PHARMACEUTICAL CO LTDPHENOBARBITAL

DMF 278272013

NANTONG JINGHUA PHARMACEUTICAL CO LTDPHENOBARBITAL

DMF 313212017

HARMAN FINOCHEM LTDPHENOBARBITAL SODIUM USP

DMF 314992017

ALKALOIDA CHEMICAL CO ZRTPHENOBARBITAL SODIUM, USP

DMF 345982020

AMRI RENSSELAER INCInactivePHENOBARBITAL SODIUM USP

DMF 161482002

CHEMISCHE FABRIK BERG GMBHInactivePHENOBARBITAL USP

DMF 234042009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 18, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/VIAL

RLD

2 patents1 exclusivity▴

POWDER;INTRAVENOUS | Approved: Nov 17, 2022

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11857683	Apr 7, 2042	—	—	Yes		—
12636254	Apr 7, 2042	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
ODE-414	Nov 17, 2029	Active