Cenobamate - Generic Drug Details

What are the generic sources for cenobamate and what is the scope of patent protection?

Cenobamate is the generic ingredient in one branded drug marketed by Sk Life and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cenobamate has twenty-six patent family members in twenty countries.

One supplier is listed for this compound.

Summary for cenobamate

International Patents:	26
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	11
Patent Applications:	73
What excipients (inactive ingredients) are in cenobamate?	cenobamate excipients list
DailyMed Link:	cenobamate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cenobamate

Constraining patent/regulatory exclusivity:

7,598,279

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for cenobamate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
SK Life Science, Inc.	Phase 3
SK Life Science	Phase 1
SK Life Science, Inc.	Phase 1

See all cenobamate clinical trials

Pharmacology for cenobamate

Mechanism of Action

Cytochrome P450 2B6 Inducers Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inducers GABA A Receptor Positive Modulators Sodium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for cenobamate

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for CENOBAMATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XCOPRI	Tablets	cenobamate	12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg	212839	2	2024-03-11

US Patents and Regulatory Information for cenobamate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-002	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-005	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-001	Mar 10, 2020		RX	Yes	Yes	7,598,279			Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-005	Mar 10, 2020		RX	Yes	No	7,598,279			Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-001	Mar 10, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for cenobamate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Angelini Pharma S.p.A	Ontozry	cenobamate	EMEA/H/C/005377 Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.	Authorised	no	no	no	2021-03-26

International Patents for cenobamate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006112685
European Patent Office	1879873	COMPOSES AZOLE NEUROTHERAPEUTIQUES (NEUROTHERAPEUTIC AZOLE COMPOUNDS)
South Africa	200709994	Neurotherapeutic Azole Compounds
Finland	C20210018
Denmark	1879873

Supplementary Protection Certificates for cenobamate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	C202130027	Spain		PRODUCT NAME: CENOBAMATO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1530; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1530; DATE OF FIRST AUTHORISATION IN EEA: 20210326
1879873	122021000027	Germany		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326
1879873	CA 2021 00015	Denmark		PRODUCT NAME: CENOBAMAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1530 20210330
1879873	CR 2021 00015	Denmark		PRODUCT NAME: CENOBAMAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1530 20210330
1879873	301106	Netherlands		PRODUCT NAME: CENOBAMAAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1530 20210330

Cenobamate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cenobamate

Introduction

Cenobamate, marketed as Xcopri in the US, is a significant anti-seizure medication developed by SK Biopharmaceuticals, a Korean biotech company. This drug has been making waves in the pharmaceutical industry with its impressive sales figures and expanding global reach. Here, we delve into the market dynamics and financial trajectory of cenobamate.

Market Performance of Cenobamate

Sales Growth

In 2023, cenobamate achieved remarkable sales of 270.8 billion won ($202.8 million) in the US market, representing a 60.1% increase from the previous year. This growth is attributed to a rapid increase in new patient prescriptions, with the total number of prescriptions reaching 26,000 by December 2023[1][2].

Prescription Trends

SK Biopharm aims to increase total prescriptions (TRx) to over 30,000 in the US, positioning cenobamate to become a leader in the prescription drug sector. The drug's success is evident from its increasing prescription rates, indicating strong market acceptance and efficacy[1].

Financial Trajectory of SK Biopharmaceuticals

Revenue and Profitability

SK Biopharmaceuticals reported a significant revenue increase of 44.2% in 2023, reaching 354.9 billion won ($265.4 million). The company also reduced its operating loss from 131.1 billion won to 37.1 billion won, marking a substantial improvement in financial health. Notably, the fourth quarter of 2023 saw the company turn a profit with an operating profit of 15.2 billion won[2].

Cost Efficiency

Despite an increase in R&D costs due to the acquisition of SK Life Science Labs, SK Biopharmaceuticals managed to keep annual administrative expenses growth at a modest 5.4%. This cost efficiency has been crucial in the company's financial turnaround[2].

Global Expansion and Licensing

International Markets

Cenobamate is not only successful in the US but is also being developed and marketed in over 30 markets globally. Licensing partners include Dong-A ST in Southeast Asia and Australia, Eurofarma in Latin America, Hikma MENA FZE in the Middle East and North Africa, Ignis Therapeutics in the Greater China Area, and Ono Pharmaceutical Co., Ltd. in Japan. Additionally, Dexcel Pharma and Paladin Labs Inc. are marketing cenobamate in Israel and Canada, respectively[4].

Patient Reach

As of 2024, more than 100,000 patients globally have been treated with cenobamate, highlighting its widespread impact on epilepsy management. This milestone coincides with the completion of SK Biopharmaceuticals’ strategic Global Partnering plan, which aims to provide access to patients in over 100 markets worldwide[4].

Budget Impact and Cost Savings

Healthcare Budget Analysis

Studies have shown that the adoption of cenobamate can lead to significant healthcare budget savings. A budget impact analysis revealed that while cenobamate adds a gross budget impact, it results in overall healthcare budget savings due to reduced medical and non-medical costs. For instance, in a Belgian healthcare context, cenobamate treatment led to a 3-year saving of €13,802,954 associated with the treatment of seizures, outpatient visits, ER visits, and hospitalizations[3][5].

Medical and Non-Medical Savings

The use of cenobamate reduces the need for subsequent treatments, monitoring, and management of seizure events, leading to substantial medical cost savings. Additionally, non-medical savings, such as reductions in productivity loss due to focal epilepsy, contribute significantly to the overall budget savings. Over a 5-year period, the total savings generated from medical and non-medical costs can offset the gross drug budget impact of cenobamate, resulting in a net saving of €31,920,955[5].

Future Plans and Expansion

New Indications and Patient Age Range

SK Biopharmaceuticals is focusing on expanding cenobamate's indications and patient age range. This strategic move is expected to further increase the drug's market share and revenue[2].

New Modality Technology Platforms

The company is also investing in new modality technology platforms such as targeted protein degradation (TPD) and radiopharmaceutical therapy (RPT). The acquisition of SK Life Science Labs has enabled the development of molecule degraders through the MOPED platform, and collaborations with companies like TerraPower are aimed at establishing a stable supply of radioactive isotopes for RPT[2].

Key Takeaways

• Strong Sales Growth: Cenobamate achieved a 60.1% increase in US sales in 2023, reaching $202.8 million.
• Global Expansion: The drug is being marketed in over 30 global markets through various licensing partners.
• Financial Turnaround: SK Biopharmaceuticals reported significant revenue growth and reduced operating losses in 2023.
• Cost Savings: Cenobamate adoption leads to substantial healthcare budget savings through reduced medical and non-medical costs.
• Future Expansion: Plans to expand indications, patient age range, and investment in new technology platforms are underway.

FAQs

Q: What is the current sales target for cenobamate in the US for 2024?

A: SK Biopharm aims to achieve an annual sales target of $311 million for cenobamate in the US this year[1].

Q: How many patients have been treated globally with cenobamate as of 2024?

A: More than 100,000 patients globally have been treated with cenobamate as of 2024[4].

Q: What are the main revenue streams for SK Biopharmaceuticals besides cenobamate sales?

A: Besides cenobamate sales, the company generates revenue from clinical trials in Asia, royalties, and partnering revenues related to SK Life Science Labs[2].

Q: How does cenobamate impact healthcare budgets?

A: Cenobamate adoption leads to significant healthcare budget savings by reducing medical and non-medical costs associated with seizure management and patient care[3][5].

Q: What are SK Biopharmaceuticals' plans for expanding cenobamate's market reach?

A: The company plans to expand cenobamate's indications and patient age range, and is also developing new modality technology platforms such as TPD and RPT[2].

Sources

1. KED Global: SK Biopharm targets $311 mn for Cenobamate US sales.
2. KBR: SK biopharmaceuticals report improved financials in 2023.
3. ISPOR: Budget impact analysis of cenobamate as novel adjunctive treatment for FOS in epilepsy patients.
4. BioSpace: SK Biopharmaceuticals Announces 100,000 Patients Globally Have Been Treated With Cenobamate.
5. ISPOR: Budget Impact Analysis of Cenobamate for Epilepsy Patients with Focal-Onset Seizures.