XCOPRI Drug Patent Profile

When do Xcopri patents expire, and what generic alternatives are available?

Xcopri is a drug marketed by Sk Life and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in twenty countries.

The generic ingredient in XCOPRI is cenobamate. One supplier is listed for this compound. Additional details are available on the cenobamate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xcopri

Xcopri was eligible for patent challenges on March 10, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 30, 2032. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for XCOPRI

International Patents:	26
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	2
Patent Applications:	61
Drug Prices:	Drug price information for XCOPRI
What excipients (inactive ingredients) are in XCOPRI?	XCOPRI excipients list
DailyMed Link:	XCOPRI at DailyMed

See drug prices for XCOPRI

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

NDA:

212839

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 XCOPRI

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

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

See all XCOPRI clinical trials

Pharmacology for XCOPRI

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

Paragraph IV (Patent) Challenges for XCOPRI

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 XCOPRI

XCOPRI is protected by two US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	212839-001	Mar 10, 2020		RX	Yes	Yes
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-006	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-003	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-002	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-004	Mar 10, 2020		RX	Yes	No

EU/EMA Drug Approvals for XCOPRI

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 XCOPRI

When does loss-of-exclusivity occur for XCOPRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Denmark

European Patent Office

Finland

Japan

Malaysia

Mexico

Netherlands

Poland

Portugal

Russian Federation

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XCOPRI around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0607529
Russian Federation	2418792	АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ (AZOLE COMPOUNDS WITH NEUTROTHERAPEUTIC ACTIVITY)
World Intellectual Property Organization (WIPO)	2006112685
Russian Federation	2007143073	АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ
Canada	2606258

Supplementary Protection Certificates for XCOPRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	132021000000101	Italy		PRODUCT NAME: CENOBAMATO(ONTOZRY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1530, 20210330
1879873	122021000027	Germany		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326
1879873	C01879873/01	Switzerland		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68051 19.05.2022
1879873	2190019-6	Sweden		PRODUCT NAME: CENOBAMATE OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF; 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

Market Dynamics and Financial Trajectory for XCOPRI

Introduction

XCOPRI, or cenobamate, is a groundbreaking antiseizure medication developed by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science. Since its FDA approval in November 2019, XCOPRI has been making significant strides in the epilepsy treatment market. Here, we delve into the market dynamics and financial trajectory of this promising drug.

FDA Approval and Initial Impact

XCOPRI was first approved by the FDA for the treatment of partial-onset seizures in adults, marking a significant milestone as the first drug discovered by a Korean company to receive FDA approval[1]. The initial approval was based on robust clinical trials, including two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study. These studies demonstrated XCOPRI's efficacy in reducing seizure occurrences compared to placebo[1].

Market Performance and Growth

Since its launch, XCOPRI has shown impressive market performance. The drug's total prescriptions (TRx) have been steadily increasing, reaching a monthly figure of 22,000 in the U.S. in 2023, with projections to grow to 30,000 monthly prescriptions in the following year[2][5].

Market Share and Penetration

XCOPRI is expected to increase its market penetration, particularly as other major epilepsy drugs, such as Vimpat, face patent expirations. This shift is anticipated to favor XCOPRI due to its high efficacy and patient preference. The drug is projected to capture a peak U.S. market share of 6.2%, similar to Vimpat's peak share[3].

Prescription Trends

The prescription trends for XCOPRI are encouraging, with the drug showing higher market shares in new prescriptions compared to total prescriptions. This indicates a preference for XCOPRI among newly diagnosed patients, which is crucial given the lifelong treatment nature of epilepsy[3].

Financial Trajectory

Revenue Projections

SK Biopharmaceuticals expects XCOPRI to generate significant revenue in the coming years. The company forecasts that XCOPRI sales in the U.S. will reach $1 billion by 2029 and jump to $3.5 billion by 2032[2][5].

Gross Profit Margin and Net Profit

XCOPRI boasts a high gross profit margin of 90%, with almost all of its revenues translating into net profit. This financial health is attributed to the drug's low cost of goods sold (COGS) ratio of less than 10%[2][5].

Break-Even and Profitability

The company anticipates that XCOPRI will help SK Biopharmaceuticals break even by the end of 2023 and turn a full-year profit in 2024, driven by the strong growth in XCOPRI revenue and limited increases in selling, general, and administrative (SG&A) expenses[3][5].

Expansion and Diversification

Therapeutic Modalities

Beyond epilepsy, SK Biopharmaceuticals is expanding its therapeutic modalities, particularly in radiopharmaceutical therapy (RPT), a new class of cancer drugs that deliver radiation therapy directly to cancer cells. This diversification aims to position the company as a global bio-tech platform[2][5].

Digital Medical Devices

The company is also venturing into digital medical devices, including electroencephalography (EEG) equipment, leveraging epilepsy clinical data. Domestic clinical trials are underway, with results expected in 2027[3].

New Administration Methods

Recently, the FDA approved two new ingestion methods for XCOPRI, including an oral suspension mixed with water for mouth administration or via a nasogastric tube. This approval addresses a significant route of administration-related impediment in epilepsy treatment, enhancing treatment adherence and efficacy[1][4].

Clinical Trials and Future Indications

XCOPRI is currently in clinical trials for expanded indications, including adult generalized seizures and pediatric seizures. These trials are expected to conclude in 2025, potentially broadening the drug's market reach[3].

Key Takeaways

• Market Growth: XCOPRI has shown strong market performance with increasing prescriptions and a projected peak U.S. market share of 6.2%.
• Financial Health: The drug boasts a high gross profit margin of 90% and is expected to generate $1 billion in U.S. sales by 2029 and $3.5 billion by 2032.
• Diversification: SK Biopharmaceuticals is expanding into radiopharmaceutical therapy and digital medical devices.
• New Administration Methods: Recent FDA approvals for new ingestion methods enhance treatment adherence and efficacy.
• Future Indications: Ongoing clinical trials aim to expand XCOPRI's indications to include adult generalized seizures and pediatric seizures.

FAQs

Q: What is XCOPRI, and what is it used for?

A: XCOPRI, or cenobamate, is an antiseizure medication approved for the treatment of partial-onset seizures in adults.

Q: When was XCOPRI approved by the FDA?

A: XCOPRI was approved by the FDA in November 2019.

Q: What are the projected sales figures for XCOPRI in the U.S.?

A: SK Biopharmaceuticals expects XCOPRI sales in the U.S. to reach $1 billion by 2029 and $3.5 billion by 2032.

Q: What is the gross profit margin of XCOPRI?

A: XCOPRI has a high gross profit margin of 90%, with almost all of its revenues translating into net profit.

Q: Is XCOPRI being considered for other indications?

A: Yes, XCOPRI is currently in clinical trials for expanded indications, including adult generalized seizures and pediatric seizures.

Sources

1. FDA Approves New Administration Methods for SK Life Science's Xcopri - Pharm Exec
2. SK Biopharmaceuticals expects $1 bil. in US sales in 2029 - Korea Times
3. SK Biopharmaceuticals - Mirae Asset Securities Co., Ltd.
4. XCOPRI Phase I Trial | AAN 2024 - DelveInsight
5. SK Biopharmaceuticals expects US$1 bln in U.S. sales in 2029 - Yonhap News Agency