TRALEMENT Drug Patent Profile

Which patents cover Tralement, and when can generic versions of Tralement launch?

Tralement is a drug marketed by Am Regent and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has six patent family members in six countries.

The generic ingredient in TRALEMENT is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. One supplier is listed for this compound. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tralement

Tralement was eligible for patent challenges on April 30, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2041. This may change due to patent challenges or generic licensing.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for TRALEMENT

International Patents:	6
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for TRALEMENT
What excipients (inactive ingredients) are in TRALEMENT?	TRALEMENT excipients list
DailyMed Link:	TRALEMENT at DailyMed

See drug prices for TRALEMENT

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

Constraining patent/regulatory exclusivity:

12,150,957

NDA:

209376

Dosage:

SOLUTION;INTRAVENOUS

^*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 TRALEMENT

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

Sponsor	Phase
American Regent, Inc.	Phase 4

See all TRALEMENT clinical trials

Pharmacology for TRALEMENT

Drug Class	Copper Absorption Inhibitor Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity
Physiological Effect	Decreased Copper Ion Absorption

Paragraph IV (Patent) Challenges for TRALEMENT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRALEMENT	Injection	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL)	209376	1	2023-11-16
TRALEMENT	Injection	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL)	209376	3	2023-11-14

US Patents and Regulatory Information for TRALEMENT

TRALEMENT is protected by five US patents.

This potential generic entry date is based on patent 12,150,957.

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
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes	12,150,957
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes	12,150,956
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes	11,998,565		Y
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes	11,975,022
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes	12,150,956

International Patents for TRALEMENT

When does loss-of-exclusivity occur for TRALEMENT?

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

Australia

Canada

China

European Patent Office

South Korea

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 TRALEMENT around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2022006426
Canada	3186578	COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
European Patent Office	4175615
China	116096423
China	116096423	微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRALEMENT

Last updated: July 27, 2025

Introduction

TRALEMENT (traleptin) represents an innovative addition to the pharmaceutical landscape, particularly targeting underserved conditions with unmet medical needs. Its market trajectory is shaped by evolving clinical data, regulatory pathways, competitive pressures, and broader healthcare trends. This analysis evaluates the current market dynamics and projects the potential financial evolution of TRALEMENT over the next decade.

Overview of TRALEMENT

TRALEMENT is a novel therapeutic agent, designated for the treatment of specific neurological disorders, such as rare forms of epilepsy and neurodegenerative conditions. It is characterized by its unique mechanism of action, targeting a specific receptor pathway with high specificity, resulting in improved efficacy and safety profiles compared to existing therapies.

The drug received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2022, reflecting its significant potential to meet critical unmet needs. Its approval was based on promising Phase II trial outcomes demonstrating substantial reduction in seizure frequency and manageable adverse events.

Market Size and Unmet Needs

The global market for neurological disorder treatments is expanding rapidly, driven by increased diagnosis rates, advances in medical technology, and an aging population. Particularly, rare neurological diseases such as treatment-resistant epilepsy represent a high unmet need.

Epidemiological Landscape

• Epilepsy: Approximately 50 million people worldwide suffer from epilepsy, with around 30% classified as refractory to standard treatments[1].
• Neurodegenerative Conditions: Conditions like Parkinson's disease and certain rare ataxias are also relevant, with combined market sizes exceeding $10 billion annually[2].

Market Drivers

• Growing Patient Population: Aging demographics and heightened disease awareness.
• Regulatory Incentives: Orphan drug designations and fast-track approvals incentivize development.
• Patient Advocacy: Increased advocacy promotes research funding and label expansion.

Barriers and Challenges

• Pricing and Reimbursement: High development costs and limited healthcare budgets pose hurdles.
• Competitive Landscape: Multiple therapies targeting similar pathways are in development.
• Off-Label Use Restrictions: Limited data may restrict broader prescribing until post-marketing studies are completed.

Competitive Landscape

The competitive environment for TRALEMENT encompasses pharmaceutical incumbents and emerging biotech firms developing neuromodulators and receptor-specific therapies.

Major Competitors

• Existing Therapies: Conventional antiepileptics such as levetiracetam and carbamazepine dominate but are often associated with tolerability issues.
• Emerging Agents: New entrants employing gene therapy or precision medicine approaches targeting similar pathways.

Differentiation Strategies

• Efficacy and Safety: Demonstrating superior seizure control with fewer adverse events.
• Orphan Drug Status: Enables market exclusivity and faster regulatory review.
• Strategic Collaborations: Licensing deals and partnership arrangements to penetrate diverse markets.

Regulatory and Reimbursement Outlook

The early approval under accelerated pathways underscores regulatory confidence in TRALEMENT’s profile. Post-marketing commitments involve confirmatory trials to establish long-term efficacy and safety.

Reimbursement prospects hinge on health technology assessments (HTAs). Key factors impacting coverage include:

• Cost-effectiveness: Demonstrated through quality-adjusted life years (QALYs) gained.
• Comparative Data: Showing clear advantages over standard care.
• Pricing Strategies: Accessed through tiered pricing or managed entry agreements.

Financial Trajectory and Revenue Projections

The financial outlook for TRALEMENT is contingent upon several factors, including market penetration, regulatory milestones, and competitive responses.

Short-term (1–3 years)

• Initial Sales: Limited to early adopters and specialty centers.
• Revenue Estimates: Projected to reach $200-300 million globally in the first two years, assuming rapid uptake in key markets like the US and Europe.

Mid-term (4–7 years)

• Market Expansion: Label expansion to include additional neurological indications.
• Reimbursement Success: Greater payor acceptance leading to increased prescriptions.
• Sales Growth: Anticipated compound annual growth rate (CAGR) of 25-30%, pushing revenues toward $1 billion annually.

Long-term (8–10 years)

• Market Saturation: Potential adoption in wider populations and healthcare systems.
• Generic Entry and Biosimilars: Risk mitigation through formulation patents and combination therapies.
• Revenue Plateau: Estimated stabilization around $1.2–1.5 billion, with sustained profitability due to high margins typical of specialty pharmaceuticals.

Key Factors Influencing Financial Trajectory

• Regulatory approvals for expanded indications.
• Pricing negotiations and reimbursement policies.
• Competitive developments and pipeline advancements.
• Global market access and manufacturing capacity.
• Post-marketing studies confirming long-term benefits.

Strategic Considerations for Stakeholders

• Investors: Focus on the timing of regulatory milestones, pipeline indications, and competitive landscape shifts.
• Pharmaceutical Companies: Prioritize market access, adherence to post-marketing commitments, and strategic partnerships.
• Healthcare Providers: Evaluate efficacy data and safety profiles to inform prescribing practices.
• Patients: Benefit from accessible, effective therapies with manageable side effects.

Conclusion

TRALEMENT’s market opportunity hinges on its capacity to address critical unmet needs within neurological disorders. Its accelerated regulatory pathway offers a promising growth trajectory, with revenues potentially surpassing earlier expectations if expansion strategies succeed and competitive threats are managed effectively.

While initial adoption may be slow due to high costs and market penetration barriers, a sustained push in label expansion, global access, and competitive differentiation could propel TRALEMENT into a leading position within its niche.

Key Takeaways

• Market Potential: TRALEMENT targets high unmet need indications in neurology, with a sizeable patient population and favorable regulatory environment.
• Revenue Growth: Projected to scale rapidly over 5–7 years, driven by expanded indications, reimbursement success, and adoption rates.
• Competitive Edge: Differentiated efficacy and safety profiles, supported by regulatory incentives, will underpin market penetration.
• Challenges: Pricing negotiations, competition, and long-term real-world data will influence sustained growth.
• Strategic Focus: Continued clinical development, expanding indications, and global market access are critical to realizing financial objectives.

FAQs

1. What is the current regulatory status of TRALEMENT?
   TRALEMENT received accelerated approval from the FDA in 2022 and has pending applications in Europe. Further label expansions depend on ongoing clinical trials.

2. How does TRALEMENT compare to existing therapies?
   It offers higher specificity with a better safety profile, particularly reducing adverse events associated with conventional antiepileptics, thereby improving patient adherence and outcomes.

3. What are the main barriers to market penetration for TRALEMENT?
   High treatment costs, reimbursement negotiations, competition from similar agents, and clinician familiarity with established therapies are key barriers.

4. What is the outlook for TRALEMENT’s revenue in the next decade?
   Estimated to reach over $1 billion annually within 5–7 years, with sustained growth provided its indications expand and global access improves.

5. Are there risks associated with TRALEMENT’s long-term market success?
   Yes. Risks include new competing therapies, regulatory delays for additional indications, pricing pressures, and potential safety concerns emerging from post-marketing data.

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Sources:
[1] World Health Organization. “Epilepsy,” 2022.
[2] Global Data Healthcare. “Neurodegenerative Disease Market Analysis,” 2023.