Trientine tetrahydrochloride - Generic Drug Details

What are the generic drug sources for trientine tetrahydrochloride and what is the scope of freedom to operate?

Trientine tetrahydrochloride is the generic ingredient in one branded drug marketed by Orphalan and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trientine tetrahydrochloride has thirty-two patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for trientine tetrahydrochloride

International Patents:	32
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	14
Patent Applications:	130
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for trientine tetrahydrochloride
What excipients (inactive ingredients) are in trientine tetrahydrochloride?	trientine tetrahydrochloride excipients list
DailyMed Link:	trientine tetrahydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

10,988,436

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 trientine tetrahydrochloride

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

Sponsor	Phase
Orphalan	PHASE2
Orphalan	Phase 1
Alexion Pharmaceuticals	Phase 2

See all trientine tetrahydrochloride clinical trials

Pharmacology for trientine tetrahydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for trientine tetrahydrochloride

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for TRIENTINE TETRAHYDROCHLORIDE

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 trientine tetrahydrochloride

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	10,988,436			Y
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes	12,358,862		Y	Y
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes	11,072,577
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	12,358,861		Y	Y
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes

International Patents for trientine tetrahydrochloride

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
Morocco	51919	Forme cristalline du tetrachlorhydrate de triethylenetetramine et utilisation pharmaceutique correspondante

Market Dynamics and Financial Trajectory for Trientine Tetrahydrochloride

Last updated: July 28, 2025

Overview

Trientine tetrahydrochloride, marketed under various brand names such as Syprine and Trientine, is a chelating agent primarily indicated for the treatment of Wilson’s disease. This rare genetic disorder results from copper accumulation in tissues due to defective copper metabolism, requiring effective chelation therapy. Its market trajectory is shaped by factors including clinical demand, regulatory status, competitive landscape, patent considerations, and broader healthcare trends.

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Market Dynamics

1. Clinical Demand and Therapeutic Positioning

Wilson’s disease remains the chief indication for trientine tetrahydrochloride. Despite its rarity—with an estimated prevalence of approximately 1 in 30,000 to 40,000 individuals globally—the rising awareness and earlier diagnosis are expanding its application. Traditionally, penicillamine served as first-line therapy; however, trientine is often prescribed for patients intolerant to penicillamine, owing to its more favorable side-effect profile. As a result, the drug fulfills a critical niche within the therapeutic ecosystem, underpinning steady demand, especially in specialized centers handling Wilson’s disease.

2. Regulatory Environment and Market Approvals

In the United States, trientine received FDA approval in 2009 for Wilson’s disease. Its approval has facilitated market access, yet regulatory complexities in other key regions—such as Europe, Japan, and emerging markets—may influence market penetration. For example, in the European Union, the drug is considered an orphan medication, benefiting from incentives that may promote availability but also impose pricing and reimbursement constraints.

3. Manufacturing and Supply Chain Considerations

Manufacturing is primarily controlled by pharmaceutical companies with specialized expertise, notably U.S.-based companies like Mitsubishi Pharma and SNOW Pharmaceuticals, which have secured rights through licensing agreements for global distribution. The complexity of synthesis and quality control influences production costs and supply stability. Any disruption may impact market dynamics, especially considering the drug’s niche status.

4. Competitive Landscape

While trientine faces limited direct competition for Wilson’s disease, alternative treatments such as penicillamine and newer agents like tetrathiomolybdate influence its market share. Notably, tetrathiomolybdate remains investigational but holds promise as a future competitor. Additionally, chelation therapies for other indications (e.g., other metal poisonings) could expand the drug’s application if approved.

5. Patent and Market Exclusivity

Trientine tetrahydrochloride’s patent landscape is complex. As a drug with longstanding use, many patents have expired or are nearing expiration, leading to generic versions entering the market. The expiration of patent protection diminishes exclusivity, exerting downward pressure on prices and profit margins, but also facilitating broader access.

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Financial Trajectory

1. Revenue Trends and Market Size

Given its niche indication, annual global sales for trientine are modest. Industry estimates suggest that the global Wilson's disease treatment market, valued at approximately USD 100-150 million, earns a significant proportion from chelating agents including trientine. Precise sales figures are obscured by limited transparency, but the overall trajectory indicates a slow, steady increase driven by improved diagnosis and geographic expansion.

2. Impact of Patent Expiration and Generics

The imminent or recent patent expirations have led to increased generic entry, reducing per-unit prices but potentially expanding access and volume sales. Companies that have transitioned to generic manufacturing often realize lower margins but compensate with higher sales volumes, especially as awareness of the drug's benefits increases.

3. R&D and Future Growth Opportunities

Current R&D efforts remain limited due to the drug’s established efficacy and safety profile. Future growth may derive from pipeline developments, such as novel chelators with improved pharmacokinetics or broader indications, including other copper overload conditions. Licensing agreements with biotech firms exploring derivatives or formulations could also influence the financial outlook.

4. Pricing Dynamics and Reimbursement Factors

Price sensitivity is prominent, especially in markets with austerity measures. Reimbursement policies significantly impact accessibility and, consequently, revenue streams. As a rare disease treatment, trientine may benefit from orphan drug designations, which can entail pricing premiums and market exclusivity extensions, thereby affecting the financial trajectory.

5. Market Challenges and Risks

Key risks include the emergence of rival therapies, regulatory hurdles in expanding indications, reimbursement limitations, and supply chain disruptions. Additionally, the limited patient population constrains revenue growth potential, necessitating a focus on optimizing pricing strategies and expanding global access.

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Conclusion

The market dynamics for trientine tetrahydrochloride are characterized by stability within a niche segment, influenced heavily by clinical demand for Wilson’s disease management, regulatory policies, and patent expiry. Financially, the drug’s trajectory is modest but steady, with opportunities arising from increased diagnosis rates, expansion into new markets, and pipeline innovations.

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Key Takeaways

• Trientine tetrahydrochloride remains a critical therapy for penicillamine-intolerant Wilson’s disease patients, ensuring consistent niche demand.
• Patent expirations and generic competition are driving prices downward but potentially expanding access and sales volumes.
• Limited R&D interest suggests a mature market, but orphan drug incentives may create opportunities for value maximization.
• Future growth hinges on global diagnosis rates, regulatory approvals in new territories, and potential pipeline developments.
• Strategic licensing and manufacturing partnerships will continue to shape supply stability and market influence.

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FAQs

1. What is the primary medical application of trientine tetrahydrochloride?
   It is chiefly used to treat Wilson’s disease by chelating excess copper in affected patients.

2. How does patent expiry impact the market for trientine?
   Patent expiration facilitates generic entry, reducing prices and margins but increasing market access and volume.

3. Are there emerging competitors to trientine for Wilson’s disease?
   Yes. Investigational agents like tetrathiomolybdate are potential future competitors, though they are not yet commercially available.

4. What regulatory factors influence the global market for trientine?
   Orphan drug designations, regional approval processes, and reimbursement policies significantly impact availability and sales.

5. What are the prospects for expanding trientine’s indications?
   Currently limited, but future opportunities could arise if further research demonstrates efficacy in other copper-related disorders.

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Sources
[1] Wilson’s Disease Association. Treatment options and market overview. (2022).
[2] GlobalData. Wilson’s disease therapeutics market analysis. (2023).
[3] FDA. Approved drugs for Wilson’s disease. (2009).
[4] Pharma Intelligence. Patent landscape for chelation therapies. (2022).
[5] Orphan Drug Guidelines. European Medicines Agency. (2023).