TRIENTINE TETRAHYDROCHLORIDE - Generic Drug Details

What are the generic 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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trientine tetrahydrochloride has eighteen patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for TRIENTINE TETRAHYDROCHLORIDE

International Patents:	18
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	13
Patent Applications:	47
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	Phase 1
Alexion Pharmaceuticals	Phase 2
Manchester University NHS Foundation Trust	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
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

International Patents for TRIENTINE TETRAHYDROCHLORIDE

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)
South Korea	20210005270	트리에틸렌테트라민 테트라클로라이드의 결정형 및 이의 약제학적 용도
Morocco	51919	Forme cristalline du tetrachlorhydrate de triethylenetetramine et utilisation pharmaceutique correspondante
Australia	2019263969	Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use
Brazil	112020018451	forma cristalina de tetracloreto de trietilenotetra-amina, composição farmacêutica, método de produção de formas cristalinas de tetracloreto de trietilenotetra-amina e forma cristalina ou composição farmacêutica
Japan	2021531322	トリエチレンテトラミン四塩酸塩の結晶形およびその医薬用途

TRIENTINE TETRAHYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trientine Tetrahydrochloride

Introduction to Trientine Tetrahydrochloride

Trientine tetrahydrochloride, marketed under the names Cuprior™ in the EU and Cuvrior™ in the US, is a copper chelating agent developed by Orphalan SA for the treatment of Wilson’s Disease, a rare inherited disorder of copper transport primarily affecting the liver and brain[1][2][5].

Market Overview

The global trientine hydrochloride market has been experiencing rapid growth, driven largely by the increasing prevalence of Wilson’s Disease and advancements in treatment formulations.

Market Size and Growth

As of 2022, the global trientine hydrochloride market was valued at USD 715.2 million. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 7.9% between 2023 and 2030, reaching USD 1,314.01 million by 2030[3].

Leading Indications and Patient Segments

Wilson’s Disease is the leading indication for trientine hydrochloride, accounting for over 58% of the market share in 2022. The adult patient segment dominates the demand, holding more than 62% of the global market share[3].

Geographical Distribution

North America is a significant contributor to the growth of the trientine hydrochloride market, holding over one-third of the market share in 2022. This region is expected to continue driving market growth due to its advanced healthcare infrastructure and higher awareness of rare diseases[3].

Key Market Drivers

Increasing Prevalence of Wilson’s Disease

The rising incidence of Wilson’s Disease is a major driver for the trientine hydrochloride market. As more cases are diagnosed, the demand for effective treatments increases[3].

Advancements in Treatment Formulations

The development of new salt forms like trientine tetrahydrochloride, which offers improved stability and ease of use compared to traditional trientine dihydrochloride, has significantly boosted the market. Trientine tetrahydrochloride is formulated as room temperature stable tablets, eliminating the need for strict cold chain storage[5].

Market Restraints

Limited Disease Awareness and Diagnosis

Despite the growing market, limited awareness and diagnosis of Wilson’s Disease in many regions act as significant restraints. Early diagnosis is crucial for effective management, but it often remains a challenge due to the rarity and complexity of the disease[3].

High Treatment Costs and Accessibility Issues

The high cost of treatment and accessibility issues, particularly in emerging markets, are major barriers to market growth. These factors limit the reach of trientine tetrahydrochloride to a broader patient population[3].

Market Opportunities

Personalized Medicine and Pharmacogenomics

The integration of personalized medicine and pharmacogenomics offers promising opportunities for the trientine hydrochloride market. Tailoring treatments to individual genetic profiles can enhance efficacy and reduce side effects, potentially increasing market demand[3].

Expansion in Emerging Markets

There is significant potential for growth in emerging markets where awareness and treatment options for Wilson’s Disease are limited. Expanding into these regions could provide new avenues for market expansion[3].

Clinical and Regulatory Milestones

FDA Approval and Orphan Drug Designation

Trientine tetrahydrochloride (Cuvrior™) has been granted FDA approval for the treatment of adult patients with stable Wilson’s Disease who are de-coppered and tolerant to penicillamine. It also holds Orphan Drug Designation in the US, which provides certain incentives for its development and commercialization[2][4].

CHELATE Trial

The CHELATE trial, a Phase 3 head-to-head study, demonstrated that trientine tetrahydrochloride was non-inferior to d-Penicillamine in maintaining therapeutic levels of non-ceruloplasmin copper (NCC) and 24-hour urinary copper excretion (UCE). This trial was pivotal in securing FDA approval and highlighting the drug's efficacy and safety profile[1][2].

Financial Trajectory

Revenue Projections

Given the projected CAGR of 7.9%, the trientine hydrochloride market is expected to see substantial revenue growth. The market is anticipated to more than double from its 2022 value by 2030, indicating a robust financial trajectory for companies involved in its production and distribution[3].

Key Players

The market is dominated by several key players, including Albany Molecular Research Inc, SMIQ Pharma, Sigma-Aldrich Co. LLC, Valeant Pharmaceuticals International Inc, and others. These companies are likely to benefit from the growing demand and advancements in treatment formulations[3].

Conclusion

The market for trientine tetrahydrochloride is poised for significant growth driven by increasing prevalence of Wilson’s Disease, advancements in treatment formulations, and expanding market opportunities. Despite restraints such as limited disease awareness and high treatment costs, the financial trajectory looks promising, with the market expected to reach USD 1,314.01 million by 2030.

Key Takeaways

• Market Growth: The global trientine hydrochloride market is expected to grow at a CAGR of 7.9% between 2023 and 2030.
• Leading Indication: Wilson’s Disease accounts for over 58% of the market share.
• Geographical Dominance: North America holds over one-third of the market share.
• Clinical Milestones: FDA approval and positive results from the CHELATE trial.
• Market Opportunities: Personalized medicine, pharmacogenomics, and expansion in emerging markets.

FAQs

Q: What is trientine tetrahydrochloride used for?

A: Trientine tetrahydrochloride is used for the treatment of adult patients with stable Wilson’s Disease who are de-coppered and tolerant to penicillamine.

Q: What is the current market size of trientine hydrochloride?

A: As of 2022, the global trientine hydrochloride market was valued at USD 715.2 million.

Q: What is the projected growth rate of the trientine hydrochloride market?

A: The market is expected to grow at a CAGR of 7.9% between 2023 and 2030.

Q: Which region dominates the trientine hydrochloride market?

A: North America holds over one-third of the market share and is a significant driver of market growth.

Q: What are the key restraints to the trientine hydrochloride market?

A: Limited disease awareness, high treatment costs, and accessibility issues are major restraints to market growth.

Sources:

1. Orphalan Announces Positive Top Line Data with Trientine Tetrahydrochloride for Maintenance Patients with Wilson’s Disease. Biospace.
2. Orphalan announces FDA approval of Cuvrior™ for the treatment of adult patients with stable Wilson’s disease. Biospace.
3. Trientine Hydrochloride Market Share, Size and Forecast 2030. Credence Research.
4. FDA Approval Document for Cuvrior™. FDA.
5. Trientine Tetrahydrochloride, From Bench to Bedside. PubMed.