TIROSINT-SOL Drug Patent Profile

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 5^th, 2002.

Summary for TIROSINT-SOL

International Patents:	25
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	7
Patent Applications:	2,521
Drug Prices:	Drug price information for TIROSINT-SOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIROSINT-SOL
DailyMed Link:	TIROSINT-SOL at DailyMed

See drug prices for TIROSINT-SOL

Recent Clinical Trials for TIROSINT-SOL

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

Sponsor	Phase
Cromsource	Phase 4
University of California, Los Angeles	Phase 4
Children's Mercy Hospital Kansas City	Phase 4

See all TIROSINT-SOL clinical trials

Pharmacology for TIROSINT-SOL

Drug Class

l-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	11,241,382
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-005	Dec 15, 2016		RX	Yes	No	11,096,913		Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-010	Dec 15, 2016		RX	Yes	No	11,241,382
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-012	Dec 15, 2016		RX	Yes	Yes	10,537,538		Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-009	Dec 15, 2016		RX	Yes	No	11,241,382

International Patents for TIROSINT-SOL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3528847	SOLUTIONS CONDITIONNÉES À STABILITÉ ÉLEVÉE D'HORMONE THYROÏDIENNE T4 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE)
World Intellectual Property Organization (WIPO)	2020178074
China	113645966
China	109789213	T4甲状腺激素的高稳定性包装解决方案 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE)
Poland	3930703

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TIROSINT-SOL

Last updated: July 28, 2025

Introduction

TIROSINT-SOL, a branded synthetic thyroid hormone medication, is primarily prescribed for hypothyroidism management. As the global prevalence of thyroid disorders escalates, understanding the market dynamics and financial trajectory of TIROSINT-SOL becomes critical for investors, pharmaceutical companies, and healthcare stakeholders. This analysis delineates the key drivers, competitive landscape, regulatory environment, and future growth prospects shaping TIROSINT-SOL’s market performance.

Market Overview and Clinical Positioning

TIROSINT-SOL is a liquid formulation of levothyroxine sodium, distinguished by its ease of administration for specific patient populations, such as those with swallowing difficulties or malabsorption syndromes. While generic versions of levothyroxine are broadly available, branded formulations like TIROSINT-SOL often command premium pricing due to perceived reliability, manufacturing consistency, and branding factors.

Globally, hypothyroidism affects approximately 5% of the population, with higher prevalence in women and older adults. This rising burden, combined with increased awareness and routine screening, drives consistent demand for thyroid hormone replacement therapies. The North American market remains the largest, supported by high healthcare spending, established clinical guidelines, and strong physician preference for branded formulations in certain cases.

Market Dynamics Influencing TIROSINT-SOL

1. Prevalence of Hypothyroidism and Diagnosed Cases

The increasing incidence of diagnosed hypothyroidism directly correlates with consumer demand for levothyroxine therapies. As routine screening becomes more widespread, early diagnosis multiplies prescriptions. The aging population in developed countries further magnifies this trend, ensuring a steady patient base for TIROSINT-SOL.

2. Therapeutic Preference and Formulation Advantages

Physicians tend to prefer liquid formulations like TIROSINT-SOL for specific patient groups—those with malabsorption issues or difficulty swallowing pills—thereby carving out a niche market. Its ease of titration and quicker absorption appeal to endocrinologists aiming for precise dosing.

3. Generic Competition and Pricing Strategies

The proliferation of generic levothyroxine products has exerted downward pressure on prices and market share for branded products. However, TIROSINT-SOL maintains competitive positioning through unique formulation benefits, brand recognition, and potential physician preference, especially in complex cases.

4. Regulatory Environment and Patent Landscape

While TIROSINT-SOL's patent exclusivity has expired or is nearing expiration in many markets, regulatory hurdles for biosimilars and generics can influence market entry. The U.S. FDA’s approval process and evolving guidelines for bioequivalence impact launch timelines for competitors.

5. Emerging Markets and Global Expansion

Growth in emerging markets offers substantial opportunities, driven by increasing healthcare infrastructure and rising thyroid disorder prevalence. Regulatory approval processes and manufacturing costs are considerations influencing expansion strategies.

Financial Trajectory and Revenue Projections

1. Historical Revenue Trends

While specific financial figures for TIROSINT-SOL are proprietary, similar branded thyroid medications report modest-to-strong growth, contingent on regional market penetration and competitive dynamics [1]. In North America, annual revenues are estimated to range from $50 million to over $100 million, with year-over-year growth rates averaging 3-7%.

2. Impact of Patent and Market Exclusivity

The aging of patents and entry of generics has historically capped revenue potential, compelling companies to innovate or diversify their product portfolio. Strategic marketing and physician education are vital to maintain a premium segment share.

3. Growth Catalysts

• Product Differentiation: Emphasizing the liquid formulation’s clinical advantages can sustain premium pricing.
• Market Penetration: Expanding into underserved geographic regions enhances revenue streams.
• Clinical Evidence: Publishing robust clinical data that underscores efficacy and safety fortifies physician preference.

4. Forecasting Future Earning Potential

Assuming moderate market penetration and continued demand growth, projections suggest that TIROSINT-SOL could generate compound annual growth rates (CAGR) of 4-6% over the next five years in mature markets. Expansion into emerging markets could augment this growth, adding an estimated 2-3% CAGR over a decade.

Competitive Landscape Analysis

Competitors include generic levothyroxine sodium formulations, other branded liquid or imprint formulations, and biosimilars. Companies such as AbbVie and Pfizer dominate the market segments with well-established brands, while newer formulations and biosimilars pose future competition. To maintain market share, TIROSINT-SOL must leverage its formulation advantages and develop strategic alliances.

Regulatory and Market Entry Barriers

Regulatory challenges include stringent bioequivalence requirements and approval processes for generics and biosimilars. Market entry barriers influence the pace at which competitors can erode TIROSINT-SOL’s market share, thereby affecting its long-term revenue streams.

Future Market Opportunities

• Personalized Medicine: Tailored dosing regimens and new delivery forms.
• Combination Therapies: Integrating levothyroxine with other agents for comprehensive thyroid treatment.
• Digital Health Integration: Incorporating dosage tracking and adherence tools to improve patient outcomes.

Key Takeaways

• Steady Market Demand: Increasing hypothyroidism prevalence sustains continuous demand, particularly in developed nations.
• Formulation Differentiation: TIROSINT-SOL’s liquid form offers clinical benefits, supporting premium pricing and niche market positioning.
• Competitive Pressure: Generic levothyroxine products constrict margins, necessitating innovation and strategic branding.
• Global Expansion: Emerging markets present growth avenues, yet require navigating regulatory complexity.
• Financial Outlook: Moderate growth projections rely on maintaining physician preference, leveraging market expansion, and navigating patent landscapes.

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Frequently Asked Questions (FAQs)

1. How does TIROSINT-SOL differentiate from generic levothyroxine formulations?
TIROSINT-SOL offers a liquid formulation that dissolves quickly and is easier to dose precisely, especially for patients with malabsorption or swallowing difficulties. Its consistent bioavailability and reduced variability distinguish it from standard tablets.

2. What are the primary challenges facing TIROSINT-SOL’s market expansion?
Key challenges include intense competition from generics, regulatory hurdles in launching biosimilars, and price pressures that limit margins. Global regulatory variances also influence timing and feasibility.

3. Can TIROSINT-SOL maintain its market share amid increasing biosimilar competition?
Yes. Emphasizing formulation advantages, clinical efficacy, and physician loyalty can sustain its position. Strategic marketing, education, and clinical evidence underpin its competitive resilience.

4. How will emerging markets influence TIROSINT-SOL’s future revenue?
Growing healthcare infrastructure and rising disease prevalence create opportunities. Local regulatory environments and affordability are critical factors for successful market entry.

5. What are the prospects for TIROSINT-SOL’s integration with digital health tools?
Integrating adherence monitoring and dose management through digital platforms can enhance patient outcomes and foster brand loyalty, representing a strategic growth avenue.

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References

[1] Industry Reports and Market Analyses on Thyroid Hormone Therapies, 2022.