Viewing data from:

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

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Phenobarbital Sodium (2023)

Total Spending

$65K

Total Claims

Beneficiaries

Avg Cost/Unit

$49.94

Spending Trend

$127K(2019)→$64K(2020)→$45K(2021)→$35K(2022)→$65K(2023)

YoY Change:+143.0%

5yr CAGR:+11.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain6 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

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)

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

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

SUN PHARM INDS INC added US Patent 12,636,254 to the Orange Book listing for SEZABY (phenobarbital sodium), NDA 215910.

New: New record