Viewing data from:

XCOPRI

NDA

CENOBAMATE | N212839 | SK LIFE SCIENCE INC

6 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

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Today

7598279

Oct. 30, 2032

11654133

Jun. 16, 2039

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
SK Biopharmaceuticals Co., Ltd et al v. Aurobindo Pharma Limited et al 1:2024cv00718 2 patentsANDA 219473, 219403cenobamate	D. Del.	2024-06-18	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cenobamate Open-Label Extension Study for YKP3089C025 NCT03961568	Phase 3	Completed	SK Life Science, Inc.	147	2019-08-13 → 2026-06-10
Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures NCT03678753	Phase 3	Completed	SK Life Science, Inc.	169	2018-10-03 → 2025-05-26

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

Medicare Part D Spending

CMS annual spending data for Xcopri (2023)

Total Spending

$113.1M

Total Claims

83,222

Beneficiaries

9,630

Avg Cost/Unit

$37.74

Spending Trend

$3.6M(2020)→$32.5M(2021)→$68.2M(2022)→$113.1M(2023)

YoY Change:+6.7%

5yr CAGR:+9.8%

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

API Supply Chain6 active DMFs

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

APICHEM LABORATORIES PRIVATE LTDCENOBAMATE

DMF 387512023

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCENOBAMATE

DMF 387802023

APITORIA PHARMA PRIVATE LTDCENOBAMATE

DMF 388142023

METROCHEM API PRIVATE LTDCENOBAMATE

DMF 406672024

OPTIMUS DRUGS PRIVATE LTDCENOBAMATE

DMF 411552025

MAITHRI DRUGS PRIVATE LTDCENOBAMATE

DMF 429012025

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Aug 19, 2025	SUPPL -13	View Letter (PDF)
Apr 8, 2024	SUPPL -9	View Letter (PDF)
Apr 8, 2024	SUPPL -10	View Letter (PDF)
Jan 29, 2024	SUPPL -8	View Letter (PDF)
Jun 28, 2022	SUPPL -7	View Letter (PDF)
Jun 28, 2022	SUPPL -6	View Letter (PDF)
Sep 1, 2020	SUPPL -1	View Letter (PDF)
Nov 22, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

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#001 — 12.5MG

RLD

2 patents0 exclusivities▴