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
Australia	2021300384	Trace element compositions, methods of making and use
China	116096423	微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application)
European Patent Office	4175615	COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
World Intellectual Property Organization (WIPO)	2022006426
South Korea	20230058047	미량 원소 조성물, 그 제조 및 사용 방법

Market Dynamics and Financial Trajectory for Tralement

Introduction

Tralement, introduced by American Regent, Inc., is the first and only FDA-approved multi-trace element injection, designed for parenteral nutrition in adult and pediatric patients weighing at least 10 kg. This article delves into the market dynamics and financial trajectory of Tralement, exploring its launch, market positioning, and the company's strategic investments.

Market Need and Indication

Tralement is indicated as a source of zinc, copper, manganese, and selenium for patients when oral or enteral nutrition is not possible, insufficient, or contraindicated. This fills a critical gap in parenteral nutrition, aligning with the recommendations of the American Society for Parenteral and Enteral Nutrition (ASPEN)[5].

Launch and Availability

The product was launched in September 2020, marking a significant milestone for American Regent. It is available for immediate shipment, and customers can order through the company's wholesaler/distributor or by contacting their Customer Support Group[1][5].

Market Positioning

Tralement is positioned as a unique solution in the parenteral nutrition market, being the first FDA-approved multi-trace element injection. This uniqueness gives American Regent a competitive edge, allowing the company to capture a significant share of the market for trace element supplementation.

Clinical Benefits and Alignment with Guidelines

The formulation of Tralement has been designed to meet the needs of a broad range of patients, adhering to ASPEN recommendations. This alignment ensures that the product is clinically beneficial and meets the high standards set by medical guidelines, which can enhance its adoption and trust among healthcare providers[1][5].

Manufacturing Infrastructure and Supply Chain

American Regent has made significant investments in its manufacturing infrastructure to ensure a continuous supply of Tralement. This investment is crucial for maintaining market presence and satisfying the demand for this critical nutritional supplement[1].

Financial Implications and Revenue Potential

While specific financial data for Tralement is not publicly disclosed, the launch of such a unique product typically generates significant revenue. The demand for parenteral nutrition solutions is steady, and with Tralement being the only FDA-approved multi-trace element injection, it is likely to capture a substantial market share. The company's commitment to expanding the product line and addressing special patient populations further indicates a robust financial trajectory.

Competitive Landscape

The parenteral nutrition market is competitive, but Tralement's FDA approval and alignment with ASPEN guidelines give it a distinct advantage. The generic drug industry dynamics, as studied by the Federal Trade Commission, suggest that unique products with FDA approval can maintain higher prices and market share compared to generic alternatives, at least until multiple competitors enter the market[3].

Strategic Expansion and Future Plans

American Regent has committed to addressing the needs of special patient populations through the expansion of the Tralement product line. This strategic move is likely to further solidify the company's position in the market and open up new revenue streams. The expansion plans indicate a proactive approach to market dynamics, ensuring the product remains relevant and in high demand[1].

Regulatory Compliance and Safety Initiatives

The launch of Tralement also demonstrates American Regent's commitment to meeting FDA safety initiatives for unapproved products. This compliance enhances the product's credibility and safety profile, which is crucial for maintaining market trust and regulatory approval[1].

Customer and Market Response

The successful launch and availability of Tralement suggest a positive market response. Healthcare providers and patients are likely to appreciate the convenience and clinical benefits of a single injection that provides multiple trace elements, which can improve patient outcomes and simplify treatment protocols.

Key Takeaways

• Unique Market Position: Tralement is the first and only FDA-approved multi-trace element injection.
• Clinical Alignment: Formulated to meet ASPEN recommendations, ensuring clinical benefits and trust among healthcare providers.
• Manufacturing Infrastructure: Significant investments to ensure continuous supply.
• Financial Potential: Likely to generate substantial revenue due to its unique status and market demand.
• Strategic Expansion: Plans to address special patient populations and expand the product line.
• Regulatory Compliance: Meets FDA safety initiatives, enhancing credibility and safety profile.

FAQs

What is Tralement used for?

Tralement is used as a source of zinc, copper, manganese, and selenium for parenteral nutrition in adult and pediatric patients weighing at least 10 kg when oral or enteral nutrition is not possible, insufficient, or contraindicated[1][5].

Who is the target market for Tralement?

The target market includes adult and pediatric patients requiring parenteral nutrition, particularly those who cannot receive oral or enteral nutrition[1][5].

What makes Tralement unique in the market?

Tralement is the first and only FDA-approved multi-trace element injection, aligning with ASPEN recommendations for trace element supplementation[1][5].

How does American Regent ensure the supply of Tralement?

American Regent has made significant investments in its manufacturing infrastructure to ensure a continuous supply of Tralement[1].

What are the future plans for Tralement?

American Regent plans to expand the Tralement product line to address the needs of special patient populations[1].

Sources

1. American Regent Introduces Tralement™ (trace elements injection 4 USP) - PR Newswire
2. Travere Therapeutics Reports First Quarter 2024 Financial Results - Travere Therapeutics
3. Generic Drug Industry Dynamics - Federal Trade Commission
4. 2024 Price Increase Report - Texas Department of State Health Services
5. American Regent Introduces Tralement™ (trace elements injection 4 USP) - BioSpace