TheraRadar
Data updated: Jun 28, 2026

SESQUIENT (fosphenytoin sodium) · Lupin

CNS Approved 2020-11-05

SESQUIENT is FDA-approved to treat 3 conditions (same as FOSPHENYTOIN SODIUM).

1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Discontinued
First Approved
2020-11-05
Patent Cliff
2033

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: FOSPHENYTOIN SODIUM

SESQUIENT Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2020 to 2020
Nov 2020 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer

What SESQUIENT Treats

3 indications

SESQUIENT is approved for 3 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Generalized tonic-clonic status epilepticus
  • Prevention and treatment of seizures occurring during neurosurgery
  • Short-term substitution for oral phenytoin when oral administration is not possible

Same approved indications as FOSPHENYTOIN SODIUM (same active ingredient).

Source: FDA Label
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Active Pipeline

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Key Completed Trials

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Trial Timeline

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SESQUIENT FDA Label Details

Indications & Usage

FDA Label (PDF)

SESQUIENT is FDA-approved to treat 3 conditions — same approved indications as FOSPHENYTOIN SODIUM.

View full patent landscape →
5 OB patents · 2 families · 87 international docs across 15 countries

SESQUIENT Patents & Exclusivity

Latest Patent: Feb 2033

Patents (5 active)

US9493582 Expires Feb 27, 2033
US8410077 Expires Mar 13, 2029
US9200088 Expires Mar 13, 2029
US9750822 Expires Mar 13, 2029
US7635773 Expires Mar 13, 2029
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2033
  • 20 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

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  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.