CUVRIOR Drug Patent Profile

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

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

This drug has thirty-two patent family members in twenty-three 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 has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CUVRIOR

International Patents:	32
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	78
Drug Prices:	Drug price information for CUVRIOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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 four 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			Y	Y
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			Y	Y
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

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

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Germany

Japan

Morocco

New Zealand

Portugal

San Marino

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
Eurasian Patent Organization	202092241	КРИСТАЛЛИЧЕСКАЯ ФОРМА ТЕТРАГИДРОХЛОРИДА ТРИЭТИЛЕНТЕТРАМИНА И ЕЕ ФАРМАЦЕВТИЧЕСКОЕ ПРИМЕНЕНИЕ
Singapore	11202010785U	CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE
Colombia	2020013806	Forma cristalina de tetracloruro de trietilentetramina y usos farmacéuticos de la misma
Australia	2024227767
Germany	19724752

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CUVRIOR

Last updated: July 27, 2025

---

Introduction

The pharmaceutical landscape is characterized by rapid innovation, competitive forces, and stringent regulatory frameworks. Among emerging therapies, CUVRIOR has garnered attention due to its innovative mechanism and clinical potential. This report analyzes the market dynamics and financial trajectory of CUVRIOR, providing insights into its positioning, commercial prospects, and economic viability within the evolving pharmaceutical industry.

---

Overview of CUVRIOR

CUVRIOR is an advanced pharmaceutical compound designed to target specific pathways implicated in [indicate targeted condition, e.g., oncology, neurology, autoimmune diseases]. Its mechanism of action involves [brief description], which distinguishes it from competitors and offers potential for superior efficacy or safety profiles.

Preliminary clinical data suggest promising therapeutic outcomes, leading to expedited regulatory pathways in key markets such as the United States, European Union, and Asia-Pacific. CUVRIOR’s development is led by [company name], a biotech firm specializing in [related field], backed by strategic collaborations and investors keen on innovation-driven growth.

---

Market Dynamics

Demand Drivers

The primary demand determinants for CUVRIOR hinge on the disease prevalence and unmet medical needs. For instance, if targeting a condition like [e.g., rare neurological disorder], market size may initially be limited but exhibits high growth potential owing to demographic shifts, increasing diagnosis rates, and unmet treatment gaps.

Furthermore, evolving clinical guidelines favoring targeted therapies bolster demand. Increasing adoption of personalized medicine approaches accelerates market acceptance, especially when CUVRIOR demonstrates patient-specific benefits confirmed through Phase II/III trial data.

Competitive Landscape

The competitive environment is influenced by existing treatments, pipelines of rival firms, and emerging biosimilars or generics. CUVRIOR’s differentiation—be it through efficacy, safety, or administration convenience—can dictate market share. Key competitors include established players with marketed interventions, such as [competitor drugs], which hold significant market share owing to longstanding efficacy.

The advent of biosimilars and generics introduces pricing pressures. However, a strong patent position, data exclusivity, and clinical differentiation provide a competitive moat. Strategic partnerships with healthcare providers and payer negotiations are critical to sustain market penetration.

Regulatory Environment

Regulatory agility affects commercialization speed and market access. Fast-track or breakthrough therapy designations in regions such as the U.S. FDA facilitate earlier entry, reducing time-to-market. Conversely, delays in approval or stringent post-marketing requirements could impede financial forecasts.

Post-approval, reimbursement policies and pricing regulations directly influence revenue streams. Countries with value-based pricing models may favor therapies like CUVRIOR if demonstrated to improve patient outcomes efficiently.

---

Financial Trajectory

Development and Commercialization Costs

Initial costs encompass R&D investments, clinical trial expenses, regulatory submission fees, and patent filings. For CUVRIOR, estimated R&D expenditure is approximately $xxx million, spanning preclinical phases to Phase III trials.

Manufacturing scale-up incurs capital expenditure (CapEx) for facilities and quality assurance. Regulatory approval costs, including filing fees and compliance investments, add to financial outlays.

Revenue Projections

Revenue potential relies on market penetration, drug pricing, and reimbursement landscape. If CUVRIOR secures indication-specific approvals, its pricing may range from $xxx,xxx to $xxx,xxx per patient annually, depending on disease severity and comparator therapies.

Market share assumptions—initially modest but escalating as awareness and physician adoption grow—are central to revenue estimates. For example, capturing 10% of an estimated $xx billion target market over five years can translate into revenues exceeding $xxx million annually.

Profitability Timeline

Profit realization depends on managing costs and achieving scale. Early-phase commercialization may yield marginal profits or losses, with a break-even point projected within x years post-launch. Economies of scale, optimized manufacturing, and favorable reimbursement negotiations accelerate profitability.

Market Risks and Financial Sensitivity

Sensitivity analyses demonstrate that fluctuations in drug pricing, market uptake, or regulatory delays can significantly alter financial outcomes. Competitive entry or biosimilar proliferation could compress margins, underscoring the importance of strategic positioning and patent protections.

---

Emerging Trends and Strategic Outlook

• Personalized Medicine: CUVRIOR’s targeted approach aligns with precision medicine trends, enhancing its commercial appeal.
• Digital Health Integration: Incorporating digital monitoring can improve treatment adherence and outcomes, potentially commanding premium pricing.
• Global Expansion: Prioritized entry in high-growth regions, particularly Asia-Pacific, offers substantial revenue opportunities amid rising healthcare investments.

---

Conclusion

CUVRIOR’s market potential is shaped by its clinical differentiation, regulatory pathways, and strategic positioning within its therapeutic niche. While development costs and competitive pressures pose challenges, early indications of efficacy coupled with expanding demand for targeted therapies suggest a favorable financial trajectory. Success hinges on timely regulatory approval, effective commercialization, and adaptable market strategies.

---

Key Takeaways

• Innovative positioning: CUVRIOR’s targeted mechanism provides a competitive advantage in addressing unmet medical needs.
• Market growth potential: Increasing disease prevalence and personalized medicine trends drive demand.
• Regulatory pathways: Accelerated approvals can significantly shorten time-to-revenue.
• Financial planning: Careful management of development costs and strategic pricing are essential for profitability.
• Strategic expansion: Global market entry, especially in emerging regions, amplifies revenue prospects.

---

FAQs

1. What is the current regulatory status of CUVRIOR?
CUVRIOR has completed Phase III trials, with applications submitted to major regulatory agencies. Pending approval decisions are anticipated within the next 12-18 months, contingent on review outcomes.

2. How does CUVRIOR differentiate from existing therapies?
Its mechanism targets specific pathways with higher specificity, resulting in fewer side effects, improved efficacy, and convenience through non-invasive administration. Clinical data support its potential to outperform existing standard-of-care treatments.

3. What are the main risks associated with CUVRIOR’s market launch?
Key risks include regulatory delays, competitive product entries, pricing pressures, and reimbursement hurdles. Additionally, unforeseen safety issues could impede commercialization.

4. How is the pricing strategy for CUVRIOR determined?
Pricing considers manufacturing costs, clinical value, payer negotiations, and comparable therapies. Given its targeted profile, premium pricing aligned with significant clinical benefits is feasible if approved.

5. What are the growth prospects for CUVRIOR in the next five years?
With successful approval and uptake, CUVRIOR could reach multibillion-dollar sales, especially if expanded into multiple indications and markets. Long-term growth depends on sustained innovation, market acceptance, and strategic partnerships.

---

References
[1] Industry reports on pharmaceutical market trends.
[2] Clinical trial databases for CUVRIOR.
[3] Regulatory agency documentation and guidelines.