• Amicable settlement reached with one of three defendants in patent litigation 
  • Settlement expected to support stable growth momentum for the XCOPRI business

Seoul, Korea, August 19, 2026 – SK Biopharmaceuticals (www.skbp.com, President and CEO: Donghoon Lee) announced that it has reached an amicable settlement with Indian generic company MSN Laboratories (“MSN”) in a U.S. patent litigation relating to its innovative anti-epilepsy drug cenobamate (U.S. brand name: XCOPRI®). The terms of the settlement are confidential.

SK Biopharmaceuticals agreed to grant MSN the right to launch a generic product in the future, subject to the scope of the company’s patent protection and related conditions. Under this settlement, the patent litigation pending between SK Biopharmaceuticals and MSN in the U.S. District Court for the District of Delaware will be terminated. This litigation concerns follow-on patents separate from cenobamate’s compound patent, and the settlement provides a basis for continuing patent protection for XCOPRI even after the compound patent expires in 2032. However, whether and when the generic product will actually be launched may vary depending on the U.S. regulatory approval process and the conditions set forth in the confidential settlement agreement between the parties.

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About SK Biopharmaceuticals
SK Biopharmaceuticals focuses on the research, development and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin its expansion into oncology through research and development efforts.

SK Biopharmaceuticals is the first and only Korean company to independently develop and commercialize an antiseizure medication, cenobamate (brand name: XCOPRI®), in the U.S. Cenobamate, which was commercially launched in the U.S. in 2020 by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, Inc. has successfully entered five major regions: North America, Europe, Asia, Central and South America, and the Middle East and North Africa.

The company has a pipeline of 12 compounds in development in both CNS disorders and oncology. For more information, visit SK Biopharmaceuticals’ website at www.SKBP.com/eng.

About XCOPRI® (cenobamate tablets) CV 
Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. Cenobamate reduces neuronal excitability through a unique dual mechanism of action, preferentially inhibiting the persistent sodium current and enhancing GABAergic inhibition at the type A γ-aminobutyric acid (GABAA) ion channel. The precise mechanism by which cenobamate exerts its therapeutic effect is unknown. 

Cenobamate is marketed under the brand name XCOPRI® in the U.S. by SK Life Science, Inc. Additionally, XCOPRI is commercialized in Canada and Israel by SK Biopharmaceuticals’ partners, Paladin Labs Inc. and Dexcel Ltd. Cenobamate is marketed as ONTOZRY® by Angelini Pharma S.p.A. in Europe, the UK, and Switzerland. 

IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI® (cenobamate tablets) CV 

DO NOT TAKE XCOPRI IF YOU: 

  • Are allergic to cenobamate or any of the other ingredients in XCOPRI. 
  • Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart. 

XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING: 

Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider. 

QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting. 

Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood. 

Liver problems: XCOPRI may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start XCOPRI and while you take XCOPRI if needed. Tell your healthcare provider right away if you have any symptoms of liver problems, such as: yellowing of the skin and eyes (jaundice), nausea, vomiting, unusual darkening of the urine, or feeling tired or weak. 

Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you. 

Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider. 

DISCONTINUATION: 

Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). 

DRUG INTERACTIONS: 

XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. 

PREGNANCY AND LACTATION: 

XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use. 

Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org. 

Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI. 

COMMON SIDE EFFECTS: 

The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired. 

These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. 

DRUG ABUSE: 

XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law. 

INDICATION: 

XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older. It is not known if XCOPRI is safe and effective in children under 18 years of age. 

Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. 

Please see full Prescribing Information. 

XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd. 

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