TIROSINT Drug Patent Profile

When do Tirosint patents expire, and when can generic versions of Tirosint launch?

Tirosint is a drug marketed by Ibsa and is included in two NDAs. There are three patents protecting this drug and five Paragraph IV challenges.

The generic ingredient in TIROSINT 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

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

Summary for TIROSINT

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	2,521
Drug Prices:	Drug price information for TIROSINT
Drug Sales Revenues:	Drug sales revenues for TIROSINT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIROSINT
What excipients (inactive ingredients) are in TIROSINT?	TIROSINT excipients list
DailyMed Link:	TIROSINT at DailyMed

See drug prices for TIROSINT

See drug sales revenues for TIROSINT

Recent Clinical Trials for TIROSINT

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 clinical trials

Pharmacology for TIROSINT

Drug Class

l-Thyroxine

Paragraph IV (Patent) Challenges for TIROSINT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIROSINT	Capsules	levothyroxine sodium	137 mcg and 175 mcg	021924	1	2022-11-04
TIROSINT	Capsules	levothyroxine sodium	200 mcg	021924	1	2021-12-30
TIROSINT	Capsules	levothyroxine sodium	112 mcg	021924	1	2020-12-18
TIROSINT	Capsules	levothyroxine sodium	88 mcg, 100 mcg and 125 mcg	021924	1	2019-08-01
TIROSINT	Capsules	levothyroxine sodium	75 mcg and 150 mcg	021924	1	2017-12-29

US Patents and Regulatory Information for TIROSINT

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	206977-012	Dec 15, 2016		RX	Yes	Yes	11,241,382
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-003	Dec 15, 2016		RX	Yes	No	11,241,382
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-009	Dec 15, 2016		RX	Yes	No	11,241,382
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-006	Dec 15, 2016		RX	Yes	No	11,096,913		Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-007	Dec 15, 2016		RX	Yes	No	10,537,538		Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-014	Jan 13, 2021		RX	Yes	No	11,241,382

Expired US Patents for TIROSINT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-007	Oct 13, 2006	7,691,411
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-009	Oct 2, 2009	7,691,411
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-004	Oct 13, 2006	7,691,411
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-011	Apr 25, 2017	7,691,411
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-006	Oct 13, 2006	7,691,411
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-005	Oct 13, 2006	7,723,390

International Patents for TIROSINT

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

Country	Patent Number	Title	Estimated Expiration
Japan	5105685
Austria	447939
Japan	2004210780	PHARMACEUTICAL FORMATION FOR THYROID HORMONE AND METHOD FOR OBTAINING THE SAME
Japan	2003081870	PHARMACEUTICAL FORMULATION FOR THYROID HORMONE
Denmark	1291021
Austria	312621

Supplementary Protection Certificates for TIROSINT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1291021	132012902104794	Italy		PRODUCT NAME: LEVOTIROXINA SODICA(ALIASINT); AUTHORISATION NUMBER(S) AND DATE(S): RVG 106848; 106850-106860, 20110407;DA 041528011/M A 041528365/M, 20120808

Market Dynamics and Financial Trajectory for TIROSINT

Last updated: July 27, 2025

Introduction

TIROSINT (liothyronine sodium) represents a critical segment within the thyroid hormone replacement therapy market. As a synthetic form of triiodothyronine (T3), TIROSINT caters to patients with hypothyroidism and other thyroid hormone deficiencies. Its market trajectory is influenced by evolving regulatory landscapes, clinical adoption trends, competing therapies, and macroeconomic factors affecting healthcare expenditure. This analysis explores the key drivers and dynamics shaping TIROSINT's market position and forecasted financial performance.

Market Overview of Thyroid Hormone Replacement Therapies

Thyroid hormone replacement therapies (THRT) serve millions globally, addressing hypothyroidism, myxedema coma, and other thyroid-related disorders. The dominant drugs include levothyroxine (T4) formulations and liothyronine (T3) options like TIROSINT. While levothyroxine remains the standard of care, T3 formulations such as TIROSINT are often reserved for specific cases—such as patients with atypical conversion of T4 to T3 or those unresponsive to levo therapies.

Market Drivers Influencing TIROSINT

1. Rising Prevalence of Hypothyroidism

According to the American Thyroid Association (ATA), hypothyroidism affects approximately 4.6% of the US population, with a higher incidence among women aged 60 and above [1]. Aging populations and increased screening contribute to early diagnosis and treatment initiation, expanding the patient base for TIROSINT.

2. Preference for Personalized Medicine

Advancements in understanding thyroid hormone physiology have fostered personalized treatment regimens. Some clinicians prefer liothyronine in combination therapies or as monotherapy in specific cases. This selective clinical use positively impacts TIROSINT demand.

3. Regulatory and Formulation Approvals

Previously, TIROSINT faced manufacturing and approval hurdles, but recent approvals and formulations improvements—including FDA approval of generic variants—have enhanced market access. The drug’s positioning as a prescription drug with clear indications sustains its market share.

4. Limited Efficacy of T4 in Certain Subpopulations

Clinical studies suggest a subset of hypothyroid patients report better symptom control with T3 supplementation [2]. This clinical niche supports ongoing demand within specialized healthcare settings.

5. Manufacturing and Pricing Strategies

Pharmaceutical companies focusing on TIROSINT leverage strategic pricing, market segmentation, and educational campaigns targeting endocrinologists and primary care providers. These efforts influence prescription patterns and revenue streams.

Market Challenges

1. Continued Dominance of Levothyroxine

Levothyroxine’s patent expiration and the availability of generic versions have increased affordability and prescribing authority. Its proven efficacy and safety profile make it the first-line therapy, constraining TIROSINT’s growth [3].

2. Concerns over T3-Related Side Effects

Potential adverse effects, such as cardiac arrhythmias, have historically limited widespread adoption of liothyronine. Although controlled dosing mitigates risk, safety concerns restrict broader utilization.

3. Healthcare Provider Preferences

Physicians often prefer well-established protocols based on extensive clinical experience. Resistance to adopting newer or less common therapies affects TIROSINT’s market penetration.

4. Cost Considerations

While generic versions reduce costs, liothyronine remains more expensive compared to levothyroxine. Insurance reimbursement policies further influence prescribing behaviors.

Financial Trajectory and Future Outlook

1. Historical Performance Trends

Over the past decade, TIROSINT’s sales have seen modest growth, primarily driven by niche clinical indications and special populations. The drug's revenue streams are relatively stable but limited by the dominance of T4 therapy. In 2022, the global liothyronine market was valued at approximately USD 200 million, with TIROSINT accounting for a significant proportion due to its prominent market presence [4].

2. Impact of Patent Cliff and Generics

Patent expirations catalyzed the entry of generic liothyronine formulations, leading to price reductions and increased accessibility. Although this hinders revenue growth per unit, it expands the patient base for off-label and specialized uses.

3. Emerging Clinical Data and Formulations

Recent research supports nuanced use of liothyronine. Development of controlled-release or combination formulations could renew interest and expand indications, contributing to revenue growth.

4. Market Expansion Opportunities

Emerging markets present significant growth potential due to increasing healthcare infrastructure and rising hypothyroidism prevalence. Strategic partnerships and regulatory approvals in countries like China and India could fortify TIROSINT’s global footprint.

5. Regulatory and Policy Impacts

Strict regulatory standards and reimbursement policies will influence sales trajectories. Advocacy for integrating T3 therapies into treatment guidelines could boost utilization rates.

6. Competitive Landscape

Competitors, including other pharmaceutical firms producing generic liothyronine, influence market dynamics. Innovative formulations and combination therapies that demonstrate improved patient outcomes could differentiate TIROSINT and drive higher revenues.

Strategic Recommendations

• Invest in Clinical Trials: Demonstrate superior efficacy and safety profiles to expand indications.
• Enhance Physician Education: Promote clinical awareness of TIROSINT’s niche roles, addressing misconceptions.
• Innovate Formulations: Develop sustained-release or combination therapies to improve adherence and outcomes.
• Expand Global Access: Focus on emerging markets with a growing hypothyroid population and limited treatment options.
• Monitor Regulatory Changes: Engage proactively with health authorities to streamline approval processes and reimbursement policies.

Conclusion

TIROSINT's market dynamics are shaped by clinical preferences, regulatory developments, and macroeconomic factors influencing healthcare expenditures. While currently positioned within a niche segment dominated by levothyroxine therapy, strategic initiatives focused on innovation, education, and global expansion can foster sustainable revenue streams. The drug’s financial trajectory will hinge on its ability to capitalize on identified patient populations and adapt to evolving treatment paradigms.

Key Takeaways

• The hypothyroidism treatment market is expanding, driven by demographic shifts and increased screening.
• TIROSINT benefits from clinical niche applications, yet faces challenges from the dominance of levothyroxine and cost considerations.
• Generic entry has generally pressured prices but expanded access, especially in emerging markets.
• Innovation in formulations and gaining broader guideline acceptance could rekindle growth prospects.
• Strategic investments in clinical research, physician engagement, and global expansion will be vital for future financial success.

FAQs

1. What is the primary clinical indication for TIROSINT?
TIROSINT is primarily indicated for hypothyroidism management, especially in patients who do not respond adequately to levothyroxine or have specific preferences for T3 therapy.

2. How does TIROSINT differ from other thyroid hormone replacements?
Unlike levothyroxine (T4), TIROSINT contains active T3, providing rapid symptom relief and precise dosing, which benefits certain patient subsets.

3. What are the main challenges faced by TIROSINT in market growth?
Major challenges include competition from generics, safety concerns regarding T3 therapy, and physician preference for T4 monotherapy.

4. Are there ongoing developments that could boost TIROSINT's market share?
Yes, innovations such as sustained-release formulations and combination therapies could improve efficacy and adherence, potentially expanding its market.

5. What strategic moves should pharmaceutical companies consider to enhance TIROSINT’s trajectory?
Investing in clinical trials, expanding global access, educating healthcare providers, and developing new formulations are key strategies.

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Sources

[1] American Thyroid Association. (2021). Hypothyroidism facts.
[2] Pilli et al., Clinical Endocrinology (2017). Efficacy of T3 in hypothyroidism.
[3] FDA Approvals Database. (2022). Levothyroxine and liothyronine approvals.
[4] MarketWatch. (2023). Global thyroid hormone market analysis.