Trientine hydrochloride - Generic Drug Details

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

Trientine hydrochloride is the generic ingredient in three branded drugs marketed by Chartwell Rx, Bausch, Accord Hlthcare, Amneal, Dr Reddys, Eci Pharms Llc, Endo Operations, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Navinta Llc, Rising, Watson Labs Teva, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for trientine hydrochloride. Eleven suppliers are listed for this compound.

Summary for trientine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	15
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	13
Patent Applications:	368
What excipients (inactive ingredients) are in trientine hydrochloride?	trientine hydrochloride excipients list
DailyMed Link:	trientine hydrochloride at DailyMed

Recent Clinical Trials for trientine hydrochloride

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

Sponsor	Phase
Orphalan	Phase 1
Alexion Pharmaceuticals	Phase 2
University of Manchester	Phase 2

See all trientine hydrochloride clinical trials

Pharmacology for trientine hydrochloride

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

Medical Subject Heading (MeSH) Categories for trientine hydrochloride

Chelating Agents

Anatomical Therapeutic Chemical (ATC) Classes for trientine hydrochloride

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

US Patents and Regulatory Information for trientine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs Teva	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	207567-001	Feb 7, 2018	AB	RX	No	No
Rising	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	212238-002	Sep 22, 2023		RX	No	No
Amneal	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	210619-001	Feb 8, 2019		DISCN	No	No
Rising	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	212238-001	Feb 20, 2020	AB	RX	No	No
Chartwell Rx	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	209415-001	Sep 16, 2019		DISCN	No	No

Trientine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trientine Hydrochloride

Introduction to Trientine Hydrochloride

Trientine hydrochloride, also known as trientine dihydrochloride, is a crucial medication used primarily for the treatment of Wilson’s disease, a genetic disorder that leads to excessive copper accumulation in the body. It is also utilized in epoxy curing processes, although its medical application dominates the market.

Market Segmentation

The global trientine hydrochloride market is segmented based on its applications, with the primary segments being Wilson’s disease treatment and epoxy curing.

Wilson’s Disease Treatment

Wilson’s disease is the leading segment, accounting for a significant share of the market. This is due to the increasing awareness and diagnosis of the disease, as well as advancements in treatment formulations and delivery methods[4].

Epoxy Curing

While epoxy curing is another application, it contributes a smaller share compared to Wilson’s disease treatment. However, it is expected to boost the market growth in the near future[1].

Geographical Insights

The market for trientine hydrochloride is geographically diverse, with different regions contributing significantly to its growth.

Asia Pacific

Asia Pacific was the largest market for trientine hydrochloride in 2020, accounting for more than 47% of the global market. China is a key country driving this growth due to increasing healthcare demands and rising awareness about health among the population[1].

Europe

Europe is the second-largest market, driven by the growing healthcare industry and an increasing number of patients suffering from Wilson’s disease. European countries are expected to continue fueling the demand for trientine hydrochloride[1].

North America

North America is also a significant market, particularly driven by the high prevalence of Wilson’s disease and advancements in treatment. The region holds over one-third of the global market share[4].

Other Regions

Latin America, the Middle East, and Africa are also expected to contribute to the market growth during the forecast period, although at a slower pace compared to the other regions[1].

Market Size and Growth

The global trientine hydrochloride market has been experiencing robust growth.

Current Market Size

In 2020, the market was valued at approximately $423.4 million[1].

Forecasted Growth

It is expected to reach $752.9 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 7.5% during the forecast period from 2021 to 2029[1].

Extended Forecast

By 2030, the market is projected to reach $1.314 billion, growing at a CAGR of 7.9% between 2023 and 2030[4].

Drivers of Market Growth

Several factors are driving the growth of the trientine hydrochloride market.

Increasing Awareness and Diagnosis

Rising awareness about Wilson’s disease and its symptoms, such as abdominal pain, jaundice, and mood changes, has led to more people seeking medical treatment, thereby increasing the demand for trientine hydrochloride[3].

Advancements in Treatment Formulations

Improvements in treatment formulations and delivery methods, including the introduction of new salt forms like trientine tetrahydrochloride (Cuvrior®), are enhancing the market[5].

Government and Private Sector Funding

Significant funding from both government and private sectors for research on Wilson’s disease is driving market growth[3].

Market Restraints

Despite the growth, there are several challenges facing the market.

Limited Disease Awareness and Diagnosis

In many regions, there is limited awareness and diagnosis of Wilson’s disease, which can restrict market growth[4].

High Treatment Costs

The high cost of treatment is a significant barrier, especially in regions with limited healthcare resources[4].

Accessibility Issues

Accessibility issues, particularly in developing economies, can hinder the widespread adoption of trientine hydrochloride[4].

Competitive Landscape

The market for trientine hydrochloride is competitive, with several key players.

Major Players

Companies such as Albany Molecular Research Inc, SMIQ Pharma, Sigma-Aldrich Co. LLC, Valeant Pharmaceuticals International Inc, and others are prominent in the market[4].

Expansion Strategies

These companies are focusing on research initiatives, innovative technologies, and expansion into emerging markets to maintain their market position[4].

Regional Insights in Wilson’s Disease Drugs Market

The Wilson’s disease drugs market, which includes trientine hydrochloride, provides additional regional insights.

North America

North America has the largest share of the Wilson’s disease drugs market, driven by factors such as rising geriatric demand and advancements in disease management[3].

Future Prospects

The future of the trientine hydrochloride market looks promising.

Personalized Medicine and Pharmacogenomics

Opportunities in personalized medicine and pharmacogenomics could further enhance the market[4].

Emerging Markets

Expansion into emerging markets for Wilson’s disease treatment is another potential growth area[4].

"Trientine tetrahydrochloride is formulated as a tablet for oral use. The recommended starting total daily dosage is 300 mg up to 3,000 mg taken orally in divided doses (two times daily)"[5].

Key Takeaways

• The global trientine hydrochloride market is driven primarily by its use in treating Wilson’s disease.
• Asia Pacific and Europe are the leading regions, with North America also contributing significantly.
• The market is expected to grow at a CAGR of 7.5% from 2021 to 2029 and reach $752.9 million by 2029.
• Advancements in treatment formulations and increasing awareness about Wilson’s disease are key drivers.
• High treatment costs and limited disease awareness are significant restraints.
• The market is competitive, with major players focusing on research and expansion strategies.

FAQs

1. What is the primary use of trientine hydrochloride?

Trientine hydrochloride is primarily used for the treatment of Wilson’s disease, a genetic disorder that leads to excessive copper accumulation in the body.

2. Which regions are the largest markets for trientine hydrochloride?

Asia Pacific and Europe are the largest markets, with Asia Pacific accounting for more than 47% of the global market in 2020.

3. What is the expected growth rate of the trientine hydrochloride market?

The market is expected to grow at a CAGR of 7.5% from 2021 to 2029 and at a CAGR of 7.9% from 2023 to 2030.

4. What are the major drivers of the trientine hydrochloride market?

Increasing awareness and diagnosis of Wilson’s disease, advancements in treatment formulations, and significant funding for research are major drivers.

5. Who are the key players in the trientine hydrochloride market?

Key players include Albany Molecular Research Inc, SMIQ Pharma, Sigma-Aldrich Co. LLC, Valeant Pharmaceuticals International Inc, and others.

Sources:

1. Acutemarketreports - Trientine Hydrochloride Market Expected to Grow at 7.5% by 2029
2. Nowpatient - Trientine Hydrochloride Coupon, Savings Card and Patient Assistance
3. Maximizemarketresearch - Wilson Disease Drugs Market: Global Industry Analysis and Forecast
4. Credenceresearch - Trientine Hydrochloride Market Share, Size and Forecast 2030
5. FDA - Trientine tetrahydrochloride (Cuvrior®) Approval Document