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

2 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
SK Biopharmaceuticals Co., Ltd. v. MSN Pharmaceuticals Inc. et al 1:2024cv01270 1 patentANDA 219436cenobamate	D. Del.	2024-11-19	Active	—
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

6 trials from ClinicalTrials.gov, 1 active, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy NCT06453213	Phase 4	Active	SK Life Science, Inc.	49	2024-10-14 → 2027-07-09
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
Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions NCT03234699	Phase 1	Completed	SK Life Science, Inc.	24	2017-02-22 → 2017-07-31
A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users NCT03509285	Phase 1	Completed	SK Life Science, Inc.	53	2017-03-08 → 2017-12-15
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures NCT01397968	Phase 2	Completed	SK Life Science, Inc.	222	2011-07-06 → 2021-01-28

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 10 NDCs

Highest NADAC/Unit

$42.99

per ea

Lowest NADAC/Unit

$3.91

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
71699020328XCOPRI 150-200 MG TITRATION PK	$42.99	EA	Brand	—	2026-08-19
71699020228XCOPRI 50-100 MG TITRATION PAK	$42.76	EA	Brand	—	2026-08-19
71699010356XCOPRI 350 MG DAILY DOSE PACK	$42.70	EA	Brand	—	2026-08-19
71699002530XCOPRI 25 MG TABLET	$39.89	EA	Brand	—	2026-08-19
71699010030XCOPRI 100 MG TABLET	$39.88	EA	Brand	—	2026-08-19
71699020030XCOPRI 200 MG TABLET	$39.87	EA	Brand	—	2026-08-19

Showing 6 of 10 NDCs.

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 20 NDCs (10 FSS, 10 Big4)

Lowest Price

$82.19

Highest Price

$2360.97

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71699-0025-30XCOPRI 25MG TABLET	$903.80	Big4	SK Life Science, Inc.	10/31/2026
71699-0025-30XCOPRI 25MG TABLET	$1160.44	FSS	SK Life Science, Inc.	10/31/2026
71699-0050-30XCOPRI 50MG TABLET	$901.60	Big4	SK Life Science, Inc.	10/31/2026
71699-0050-30XCOPRI 50MG TABLET	$1180.48	FSS	SK Life Science, Inc.	10/31/2026
71699-0100-30XCOPRI 100MG TABLET	$901.34	Big4	SK Life Science, Inc.	10/31/2026
71699-0100-30XCOPRI 100MG TABLET	$1180.48	FSS	SK Life Science, Inc.	10/31/2026

Showing 6 of 20 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Xcopri (2024)

Total Spending

$164.7M

Total Claims

117,028

Beneficiaries

12,500

Avg Cost/Unit

$38.43

Spending Trend

$3.6M(2020)→$32.5M(2021)→$68.2M(2022)→$113.1M(2023)→$164.7M(2024)

YoY Change:+1.8%

5yr CAGR:+7.7%

Source: CMS Medicare Part D Spending by Drug (2024). 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)

Sort:

#001 — 12.5MG

RLD

2 patents0 exclusivities▴