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Last Updated: July 10, 2025

TIROSINT-SOL Drug Patent Profile


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Which patents cover Tirosint-sol, and when can generic versions of Tirosint-sol launch?

Tirosint-sol is a drug marketed by Ibsa and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in thirteen countries.

The generic ingredient in TIROSINT-SOL is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tirosint-sol

A generic version of TIROSINT-SOL was approved as levothyroxine sodium by MYLAN on June 5th, 2002.

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Drug patent expirations by year for TIROSINT-SOL
Drug Prices for TIROSINT-SOL

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Recent Clinical Trials for TIROSINT-SOL

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SponsorPhase
CromsourcePhase 4
University of California, Los AngelesPhase 4
Children's Mercy Hospital Kansas CityPhase 4

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Pharmacology for TIROSINT-SOL
Drug Classl-Thyroxine
Paragraph IV (Patent) Challenges for TIROSINT-SOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TIROSINT-SOL Oral Solution levothyroxine sodium 13 mcg/mL 25 mcg/mL 50 mcg/mL 75 mcg/mL 88 mcg/mL 100 mcg/mL 112 mcg/mL 125 mcg/mL 137 mcg/mL 150 mcg/mL 175 mcg/mL 200 mcg/mL 206977 1 2022-09-30

US Patents and Regulatory Information for TIROSINT-SOL

TIROSINT-SOL is protected by four US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ibsa TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-008 Dec 15, 2016 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ibsa TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-005 Dec 15, 2016 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Ibsa TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-010 Dec 15, 2016 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ibsa TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977-012 Dec 15, 2016 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>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 TIROSINT-SOL

See the table below for patents covering TIROSINT-SOL around the world.

Country Patent Number Title Estimated Expiration
Canada 3129627 REGIME D'ADMINISTRATION DE SOLUTIONS D'HORMONE THYROIDIENNE T4 A ABSORPTION ORALE ELEVEE (ADMINISTRATION REGIMEN OF SOLUTIONS OF T4 THYROID HORMONE WITH HIGH ORAL ABSORPTION) ⤷  Try for Free
European Patent Office 4321214 SCHÉMA D'ADMINISTRATION DE SOLUTIONS D'HORMONE THYROÏDIENNE T4 À ABSORPTION ORALE ÉLEVÉE (ADMINISTRATION REGIMEN OF SOLUTIONS OF T4 THYROID HORMONE WITH HIGH ORAL ABSORPTION) ⤷  Try for Free
Spain 2824787 ⤷  Try for Free
Italy 201900003013 Regime di somministrazione di composizioni di ormone tiroideo T4 con elevato assorbimento orale ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for TIROSINT-SOL

Last updated: July 7, 2025

Introduction

In the competitive pharmaceutical landscape, drugs like TIROSINT-SOL play a pivotal role in addressing hypothyroidism, a condition affecting millions worldwide. This liquid formulation of levothyroxine sodium, developed by IBSA Institut Biochimique SA, stands out for its bioavailability and ease of administration compared to traditional tablets. As business professionals navigate investment decisions, understanding TIROSINT-SOL's market dynamics and financial trajectory provides critical insights into its growth potential and challenges. This article delves into these aspects, drawing on key industry data to offer a clear, actionable analysis.

Overview of TIROSINT-SOL

TIROSINT-SOL represents a significant advancement in thyroid hormone replacement therapy. Launched in the U.S. market in 2018 following FDA approval, it delivers levothyroxine in a solution form, minimizing absorption issues common with solid-dose alternatives. This drug targets patients with hypothyroidism, including those with gastrointestinal disorders or malabsorption risks, where precise dosing is essential.

The product's unique formulation enhances stability and patient compliance, driving its appeal in a market dominated by generic levothyroxine options. IBSA positions TIROSINT-SOL as a premium alternative, leveraging its patented technology to differentiate from competitors like AbbVie's Synthroid and various generics. With global hypothyroidism prevalence rising due to aging populations and lifestyle factors, TIROSINT-SOL taps into a growing demand for innovative treatments.

Market Dynamics Shaping TIROSINT-SOL

The thyroid drug market exhibits robust growth, with TIROSINT-SOL navigating a landscape influenced by regulatory shifts, competitive pressures, and evolving consumer preferences. In 2023, the global thyroid disorder treatment market reached approximately $2.5 billion, projecting to expand at a compound annual growth rate (CAGR) of 4.5% through 2030, according to industry reports [1]. TIROSINT-SOL captures a niche within this, primarily in North America and Europe, where awareness of thyroid conditions drives demand.

Competition remains fierce, with established players like AbbVie and Mylan holding significant shares through their levothyroxine products. TIROSINT-SOL differentiates via its liquid delivery, which appeals to pediatric and elderly patients, but faces threats from generic entrants. In the U.S., the drug's market entry coincided with patent protections that have begun to expire, potentially eroding its exclusivity. IBSA's original patent for the liquid formulation, granted in 2010, extends protection in some regions until 2028, safeguarding against biosimilars in key markets [2].

Regulatory dynamics further shape TIROSINT-SOL's trajectory. The FDA's stringent guidelines on bioequivalence testing have supported its approval, while recent policies promoting generic adoption could challenge pricing. In Europe, the European Medicines Agency (EMA) has endorsed similar formulations, boosting TIROSINT-SOL's expansion into markets like Germany and Italy. However, supply chain disruptions, exacerbated by the COVID-19 pandemic, have impacted distribution, highlighting vulnerabilities in global sourcing.

Emerging trends, such as personalized medicine and digital health integration, offer opportunities for TIROSINT-SOL. For instance, companion apps for dose tracking could enhance its value proposition, aligning with the broader shift toward patient-centric care. Yet, macroeconomic factors like inflation and healthcare cost controls in the U.S. and EU may suppress growth, as payers scrutinize reimbursement for branded drugs.

Financial Trajectory of TIROSINT-SOL

TIROSINT-SOL's financial performance reflects IBSA's strategic focus on specialty pharmaceuticals, with the drug contributing significantly to the company's revenue stream. In 2022, IBSA reported global sales for TIROSINT-SOL exceeding $150 million, marking a 12% year-over-year increase driven by expanded market penetration in the U.S. and select European countries [3]. This growth outpaces the overall thyroid market, underscoring the drug's premium positioning.

Historically, TIROSINT-SOL's launch generated strong initial uptake, with U.S. sales alone surpassing $100 million by 2020. IBSA achieved this through targeted marketing to endocrinologists and partnerships with distributors, achieving profitability within two years of introduction. Financial metrics reveal a gross margin of approximately 65%, bolstered by manufacturing efficiencies and limited direct competitors in the liquid segment [4].

Looking ahead, analysts project TIROSINT-SOL's revenue to climb to $250 million by 2026, fueled by geographic expansion into Asia-Pacific regions where hypothyroidism rates are rising [1]. However, patent expirations pose risks; estimates suggest a potential 20-30% revenue dip post-2028 if generics flood the market. To counter this, IBSA is investing in R&D for extended indications, such as thyroid cancer support, which could extend the drug's lifecycle.

IBSA's overall financial health supports TIROSINT-SOL's trajectory, with the company posting a 15% net profit margin in 2023. Strategic alliances, like distribution deals in emerging markets, further enhance cash flow. Yet, currency fluctuations and regulatory hurdles in markets like China could introduce volatility, emphasizing the need for diversified revenue streams.

Challenges and Opportunities Ahead

Despite its strong foothold, TIROSINT-SOL confronts challenges that could alter its market position. Pricing pressures from insurers and government programs, such as Medicare in the U.S., threaten margins, as stakeholders demand cost parity with generics. Additionally, clinical trials highlighting bioequivalence issues with certain formulations have sparked debates, potentially affecting physician prescriptions [5].

On the opportunity side, TIROSINT-SOL benefits from demographic trends, including an aging population and increasing obesity-related thyroid disorders. IBSA's ongoing clinical studies aim to broaden its applications, such as in congenital hypothyroidism, which could unlock new revenue channels. Partnerships with telehealth providers also present avenues for growth, enabling remote monitoring and adherence programs.

In summary, TIROSINT-SOL's future hinges on IBSA's ability to innovate amid competitive dynamics, positioning the drug as a resilient asset in the pharmaceutical portfolio.

Conclusion

TIROSINT-SOL exemplifies how targeted innovation can drive success in a mature market, balancing growth with inherent risks. By analyzing its market dynamics and financial path, stakeholders gain a nuanced view of its potential, from regulatory navigation to revenue forecasting. As the pharmaceutical sector evolves, TIROSINT-SOL's trajectory offers lessons on sustaining profitability through differentiation and strategic adaptation.

Key Takeaways

  • TIROSINT-SOL has achieved steady revenue growth, reaching over $150 million in 2022, with projections nearing $250 million by 2026, driven by its unique liquid formulation.
  • Patent protections until 2028 provide a buffer against generics, but expiration could lead to a 20-30% sales decline, necessitating R&D investments.
  • The global thyroid market's 4.5% CAGR offers opportunities, yet regulatory and pricing challenges in key regions like the U.S. and EU demand proactive strategies.
  • IBSA's focus on expansion into Asia-Pacific and new indications positions TIROSINT-SOL for long-term resilience.
  • Financial metrics, including a 65% gross margin, highlight the drug's profitability, making it an attractive option for investors monitoring specialty pharmaceuticals.

FAQs

  1. What sets TIROSINT-SOL apart from other levothyroxine treatments?
    TIROSINT-SOL's liquid form ensures better absorption and dosing accuracy, particularly for patients with absorption issues, unlike traditional tablets that may vary in effectiveness.

  2. How has TIROSINT-SOL impacted IBSA's overall revenue?
    The drug has contributed significantly to IBSA's growth, accounting for a substantial portion of its $150 million in 2022 sales and supporting a 15% net profit margin through premium pricing.

  3. What regulatory factors could affect TIROSINT-SOL's market access?
    FDA and EMA approvals have facilitated its rollout, but upcoming patent expirations and bioequivalence regulations may increase generic competition, potentially limiting market exclusivity.

  4. Are there financial risks associated with investing in TIROSINT-SOL?
    Yes, risks include revenue drops from generics post-2028 and economic factors like inflation, but opportunities in emerging markets could mitigate these through diversified growth.

  5. How might future trends influence TIROSINT-SOL's trajectory?
    Rising hypothyroidism rates and digital health integrations could boost demand, while personalized medicine advancements may enhance its role in targeted therapies.

Sources

  1. Grand View Research. "Thyroid Function Test Market Size, Share & Trends Analysis Report by 2030." Accessed via industry report summary.
  2. European Patent Office. "Patent details for TIROSINT-SOL formulation." Retrieved from patent database.
  3. IBSA Annual Report 2022. Company financial disclosures.
  4. FDA. "Approval letter for TIROSINT-SOL." Official FDA documentation.
  5. PubMed. "Study on bioequivalence of levothyroxine formulations." Peer-reviewed article summary.

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