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Last Updated: December 21, 2024

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TRALEMENT Drug Patent Profile


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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 three 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.

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

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Summary for TRALEMENT
International Patents:6
US Patents:3
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
Drug patent expirations by year for TRALEMENT
Drug Prices for TRALEMENT

See drug prices for TRALEMENT

Recent Clinical Trials for TRALEMENT

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

SponsorPhase
American Regent, Inc.Phase 4

See all TRALEMENT clinical trials

Pharmacology for TRALEMENT
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 three US patents and one FDA Regulatory Exclusivity.

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 11,975,022 ⤷  Subscribe ⤷  Subscribe
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-002 Dec 2, 2020 RX Yes Yes 11,786,548 ⤷  Subscribe Y ⤷  Subscribe
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-001 Jul 2, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-002 Dec 2, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-001 Jul 2, 2020 RX Yes Yes 11,998,565 ⤷  Subscribe Y ⤷  Subscribe
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-001 Jul 2, 2020 RX Yes Yes 11,786,548 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for TRALEMENT

See the table below for patents covering TRALEMENT around the world.

Country Patent Number Title Estimated Expiration
China 116096423 微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application) ⤷  Subscribe
European Patent Office 4175615 COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2022006426 ⤷  Subscribe
Canada 3186578 COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) ⤷  Subscribe
South Korea 20230058047 미량 원소 조성물, 그 제조 및 사용 방법 ⤷  Subscribe
Australia 2021300384 Trace element compositions, methods of making and use ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

TRALEMENT Market Analysis and Financial Projection Experimental

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

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