CUVRIOR Drug Patent Profile

When do Cuvrior patents expire, and when can generic versions of Cuvrior launch?

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

This drug has twenty-one patent family members in seventeen countries.

The generic ingredient in CUVRIOR is trientine tetrahydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trientine tetrahydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Cuvrior

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 3, 2039. 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 CUVRIOR

International Patents:	21
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	19
Drug Prices:	Drug price information for CUVRIOR
What excipients (inactive ingredients) are in CUVRIOR?	CUVRIOR excipients list
DailyMed Link:	CUVRIOR at DailyMed

See drug prices for CUVRIOR

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

NDA:

215760

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.

Pharmacology for CUVRIOR

Drug Class	Copper Chelator
Mechanism of Action	Copper Chelating Activity Metal Chelating Activity

Paragraph IV (Patent) Challenges for CUVRIOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUVRIOR	Tablets	trientine tetrahydrochloride	300 mg	215760	1	2023-06-21

US Patents and Regulatory Information for CUVRIOR

CUVRIOR is protected by two US patents and two FDA Regulatory Exclusivities.

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
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes				Y
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes

International Patents for CUVRIOR

When does loss-of-exclusivity occur for CUVRIOR?

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

Argentina

Australia

Brazil

Canada

China

Colombia

Eurasian Patent Organization

European Patent Office

Germany

Japan

Morocco

Saudi Arabia

Singapore

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 CUVRIOR around the world.

Country	Patent Number	Title	Estimated Expiration
China	114394904	三亚乙基四胺四盐酸盐的晶形及其医药用途 (Crystalline forms of triethylenetetramine tetrahydrochloride and medical uses thereof)
Colombia	2020013806	Forma cristalina de tetracloruro de trietilentetramina y usos farmacéuticos de la misma
European Patent Office	3652145	FORME CRISTALLINE DU TÉTRACHLORHYDRATE DE TRIÉTHYLÈNETÉTRAMINE ET UTILISATION PHARMACEUTIQUE CORRESPONDANTE (CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE)
Morocco	58726	Forme cristalline du tétrachlorhydrate de triéthylènetétramine et utilisation pharmaceutique correspondante

Market Dynamics and Financial Trajectory for Cuvrior

Introduction to Cuvrior

Cuvrior, a novel trientine tetrahydrochloride (TETA-4HCl), is a recently approved drug by the United States Food and Drug Administration (FDA) for the treatment of adult patients with stable Wilson disease who have undergone copper reduction therapy and exhibited tolerance to D-penicillamine. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Regulatory Status

Cuvrior was approved by the FDA in April 2022 and was granted Orphan Drug Exclusivity (ODE) for this specific patient population. This exclusivity provides Orphalan SA, the developer, with a period of market exclusivity, protecting the drug from generic competition for a specified period[4].

Market Need and Target Population

Wilson disease is a rare genetic disorder characterized by excessive accumulation of copper in the body, particularly in the liver, brain, and other vital organs. The approval of Cuvrior addresses a significant need for effective and safe treatment options for patients with this condition. The target population includes adult patients who are de-coppered and tolerant to D-penicillamine, a common treatment for Wilson disease[4].

Market Size and Growth

The rare neurological disease treatment market, which includes treatments for Wilson disease, is experiencing strong growth. This market is projected to grow from $8.98 billion in 2023 to $9.79 billion in 2024, with a compound annual growth rate (CAGR) of 9.0%. By 2028, the market is expected to reach $13.41 billion at a CAGR of 8.2%[3].

Key Drivers of Growth

• Advancements in Precision Medicine: The development of patient-centric drug development approaches and the integration of real-world evidence are driving growth in the rare neurological disease treatment market.
• Technological Innovations: The application of artificial intelligence, machine learning, and blockchain in drug discovery and development is enhancing the efficiency and effectiveness of treatments.
• Orphan Drug Designations: Drugs like Cuvrior, which receive orphan drug designations, benefit from regulatory incentives and market exclusivity, encouraging innovation in rare disease treatments[3].

Financial Performance and Projections

Revenue Potential

Given the exclusive market position and the growing demand for effective treatments in rare neurological diseases, Cuvrior is poised to generate significant revenue. The commercial launch in the US and Europe, as announced by Orphalan SA, marks the beginning of this revenue stream. While specific revenue projections for Cuvrior are not publicly available, the overall market growth and the drug's unique position suggest a promising financial trajectory[4].

Operational Costs and Funding

Orphalan SA, the company behind Cuvrior, has been managing its financial resources to support the development and commercialization of this drug. For instance, in the third quarter of 2024, Orphalan reported research and development expenses of $3.2 million, which is lower than the $4.2 million in the same period of 2023. The company also reported a net loss of $4.9 million for the third quarter of 2024 but emphasized that their cash reserves are sufficient to fund planned development programs through the coming 12 months[2].

Distribution and Accessibility

Cuvrior is now available in the US, with distribution partners having the drug stocked and ready for immediate use. The oral administration of Cuvrior offers dosing flexibility and portability, making it more accessible to patients. Physicians can discuss the availability of Cuvrior with their patients, and important prescribing information is readily available[4].

Competitive Landscape

The rare neurological disease treatment market is characterized by a focus on innovative and specialized treatments. Companies like Orphalan SA are directing their efforts towards creating unique solutions to solidify their market positions. Cuvrior’s approval and exclusivity provide a competitive edge, but the market remains dynamic with ongoing research and development in other treatments for Wilson disease and related conditions[3].

Key Takeaways

• Regulatory Approval: Cuvrior received FDA approval and orphan drug exclusivity in April 2022.
• Market Growth: The rare neurological disease treatment market is growing, driven by advancements in precision medicine and technological innovations.
• Revenue Potential: Cuvrior is expected to generate significant revenue due to its exclusive market position and growing demand.
• Financial Management: Orphalan SA is managing its financial resources to support the development and commercialization of Cuvrior.
• Accessibility: Cuvrior is now available in the US, offering flexible dosing and portability.

FAQs

What is Cuvrior used for?

Cuvrior is used for the treatment of adult patients with stable Wilson disease who have undergone copper reduction therapy and exhibited tolerance to D-penicillamine.

Who developed Cuvrior?

Cuvrior was developed by Orphalan SA, an international orphan drug development and commercialization company.

What is the regulatory status of Cuvrior?

Cuvrior was approved by the FDA in April 2022 and was granted Orphan Drug Exclusivity (ODE) for this specific patient population.

How is the market for rare neurological disease treatments growing?

The market is projected to grow from $8.98 billion in 2023 to $13.41 billion by 2028, with a CAGR of 8.2%, driven by advancements in precision medicine and technological innovations.

What are the key drivers of growth for Cuvrior?

Key drivers include advancements in precision medicine, technological innovations, and the exclusive market position due to orphan drug designation.

Sources

1. FDA New Drug Therapy Approvals 2022 - FDA
2. Cocrystal Pharma Reports Third Quarter 2024 Financial Results - Cocrystal Pharma
3. Rare Neurological Disease Treatment Global Market Report 2024 - Research and Markets
4. Orphalan Announces US Commercial Launch of Cuvrior - BioSpace