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
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-003	Dec 15, 2016		RX	Yes	No
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-009	Dec 15, 2016		RX	Yes	No
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-006	Dec 15, 2016		RX	Yes	No			Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-007	Dec 15, 2016		RX	Yes	No			Y

Expired US Patents for TIROSINT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-004	Oct 13, 2006
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-009	Oct 2, 2009
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-006	Oct 13, 2006
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-013	Aug 1, 2007
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-005	Oct 13, 2006

International Patents for TIROSINT

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1433478	Formes de dosage contenant des hormones thyroidiennes et procédé de préparation de ces formes (Pharmaceutical formulae for thyroid hormones and procedures for obtaining them)
Canada	2454050	PREPARATIONS PHARMACEUTIQUES POUR HORMONES THYROIDIENNES ET PROCEDES POUR OBTENIR CELLES-CI (PHARMACEUTICAL FORMULAE FOR THYROID HORMONES AND PROCEDURES FOR OBTAINING THEM)
European Patent Office	1291021	Formulations pharmaceutiques comprenant des hormones thyroidiennes (Pharmaceutical formulations for thyroid hormones)
Canada	2392545	PREPARATIONS PHARMACEUTIQUES POUR HORMONES THYROIDIENNES (PHARMACEUTICAL FORMULATIONS FOR THYROID HORMONES)
Japan	4851064

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 (Liothyronine Sodium)

Last updated: December 26, 2025

Executive Summary

TIROSINT (liothyronine sodium) is a synthetic form of triiodothyronine (T3), used primarily to treat hypothyroidism and certain thyroid-related disorders. While historically a niche product, recent shifts in thyroid health management, regulatory environment, and competitive landscape are influencing its market trajectory. This article examines the key market forces, financial trends, competitive positioning, regulatory landscape, and growth prospects for TIROSINT up to 2023.

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Overview of TIROSINT

Attribute	Details
Generic Name	Liothyronine Sodium
Brand Name	TIROSINT (manufactured by Perrigo)
Therapeutic Class	Thyroid hormone replacement
Approved Uses	Hypothyroidism, myxedema coma, thyroid suppression tests
Formulation	Oral tablets (commonly 25 mcg, 50 mcg)

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Market Fundamentals

Global Market Size & Trends

Parameter	2023 Estimate	Historical CAGR (2018-2023)	Source
Global Thyroid hormone market	~$740 million	4-6%	[1]
Liothyronine segment share	Approx. 20% (of thyroid hormone market)	–	[2]

The global thyroid hormone market, valued at around $740 million in 2023, is expanding steadily due to rising thyroid disorder prevalence. TIROSINT results constitute roughly 20% of this market, with the remainder predominantly comprising levothyroxine (T4) products.

Key Market Drivers

• Increasing prevalence of hypothyroidism: Approximately 4.6% of the US population has hypothyroidism, often requiring hormone replacement therapy ([3]).
• Aging populations: Older adults are at higher risk, boosting demand.
• Physician prescribing patterns: While levothyroxine remains dominant, a subset of clinicians prefer T3-containing therapies, including TIROSINT.
• Regulatory reclassifications: In various markets, regulatory decisions influence prescription and availability.

Market Challenges

• Limited clinical confidence in T3 monotherapy: Regulatory agencies, such as the FDA, maintain rigorous standards due to historical safety concerns.
• Generic competition: Although Perrigo’s TIROSINT holds market share as a branded product, multiple generics have entered markets like the U.S., exerting pricing pressure.
• Concerns over safety and efficacy: Some clinicians express caution over T3 therapy's cardiovascular risks, impacting prescribing behaviors.

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Competitive Landscape

Product	Formulation	Market Share (2023)	Manufacturers	Key Notes
TIROSINT	25/50 mcg tablets	~60% (US)	Perrigo	Branded, FDA-approved
Generic Liothyronine	25/50 mcg	25-30%	Multiple	Price-sensitive segment
Other Brands	Variable	<10%	Various	Limited geographic presence

Key Competitors and Alternatives

Product	Type	Status	Notes
Cytomel (liothyronine, Janssen)	Brand generic	Discontinued in some markets	Previously dominant; replaced by generics
Off-label formulations	Customs preparations	Variable	Regulatory restrictions in some markets

Market Trends

The shift toward generic products increases price competition but may limit margins for branded drugs like TIROSINT. Nonetheless, branded formulations retain loyalty based on quality assurance and regulatory approval.

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Regulatory and Policy Environment

Regulatory Approvals & Access

• U.S. FDA: TIROSINT approved as a prescription drug; generics also approved, creating competitive pricing.
• EU Regulation: Similar approval processes; some markets favor generic substitution.
• Reimbursement Policies: Reimbursement rates influence provider prescribing—branded TIROSINT often enjoys broader coverage due to perceived quality and safety.

Pharmacovigilance & Safety

Concerns about T3 therapy’s cardiovascular risks have prompted regulatory guidance:

• FDA (2020): Emphasizes cautious prescribing, especially for older adults.
• EMA: Recommends monitoring when initiating T3 therapy.

Adherence to guidelines impacts market adoption and limits overuse.

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Market Dynamics: Drivers, Restraints, and Opportunities

Drivers

Factor	Impact	Details
Rising thyroid disorder prevalence	Growth in demand	Prevalence increasing due to lifestyle factors and aging
Clinical preference for T3 therapy	Niche expansion	Some endocrinologists prefer T3 monotherapy in specific cases
Regulatory stability	Market confidence	Approval of branded TIROSINT sustains market presence

Restraints

Factor	Impact	Details
Competition from generics	Margin compression	Multiple low-cost alternatives limit pricing power
Safety concerns	Prescribing hesitance	Cardiovascular risks deter widespread use
Limited awareness & research	Clinical inertia	Smaller clinical studies hinder broader acceptance

Opportunities

Factor	Potential	Details
Expanding indications	New patient segments	Exploring off-label or adjunct uses, e.g., in euthyroid sick syndrome
Geographic expansion	Untapped markets	Emerging economies with rising thyroid disease rates
Formulation innovation	Enhanced delivery	Development of sustained-release formulations

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Financial Trajectory Analysis

Revenue Projections (2023-2028)

Scenario	Revenue Estimate ($ millions)	Growth Rate	Assumptions
Conservative	100	2-3% CAGR	Market stagnation, high generic penetration
Moderate	150	7-8% CAGR	Increased prescriber confidence, optimal market penetration
Optimistic	200	12-15% CAGR	Expanded indications, geographic growth

Key Assumptions:

• Continued generic competition suppresses margins but maintains volume.
• Regulatory and safety perceptions influence prescribing patterns.
• Pricing strategies and reimbursement policies significantly affect revenues.

Cost Factors & Profitability

Cost Components	Estimates	Impact
Manufacturing & Supply Chain	$10-15 per 50 mcg tablet	Economies of scale improve margins
R&D investments	Variable	Mainly for formulation improvements
Marketing & Distribution	15-20% of revenue	Critical for physician awareness

Profitability Outlook

Branded TIROSINT's profitability hinges on maintaining regulatory exclusivity, managing generic threat, and optimizing supply chain efficiencies.

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Comparison with Other Thyroid Replacement Therapies

Parameter	Thyroxine (T4)	Liothyronine (T3)	Combination (T3/T4)
Market Size	~$600 million	~$150 million	Growing niche
Safety Profile	Well-established	Cardio risk concerns	Evolving evidence
Prescriptions	>90% of hypothyroid cases	~10-15%	Selective prescribing

TIROSINT remains niche but strategically relevant for specific patient groups and specialty prescribing.

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Regulatory & Scientific Evidence Impact

Recent publications such as the 2019 NICE guidelines favor levothyroxine monotherapy but note T3 use in certain cases; this influences market trajectory. Conversely, improvements in formulations like TIROSINT, showing consistent bioavailability, bolster therapeutic confidence.

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Future Outlook and Recommendations

Aspect	Potential Impact	Strategic Recommendations
Market Expansion	Geographic, indication growth	Enter emerging markets, explore new therapeutic niches
Clinical Evidence	Increased acceptance	Invest in clinical trials demonstrating safety & efficacy
Formulation Innovation	Competitive advantage	Develop sustained-release or combo formulations
Regulatory Engagement	Market stability	Proactively align with guidelines & safety standards

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Key Takeaways

• TIROSINT's market is characterized by a stable but niche segment constrained by generic competition, safety concerns, and clinician preferences.
• Revenue is forecasted to grow modestly, underpinning the importance of geographic expansion, clinical research, and formulation innovation.
• The regulatory environment remains pivotal; positive clinical evidence and safety profiles could expand T3 therapy acceptance.
• Competitive differentiation will rely on quality assurance, supply chain efficiencies, and strategic positioning within thyroid disorder management paradigms.
• Overall, TIROSINT presents a calculated growth opportunity for stakeholders prepared to navigate its complex market dynamics.

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Frequently Asked Questions (FAQs)

1. What factors influence the prescribing of TIROSINT over other thyroid medications?
Physicians may choose TIROSINT in cases where patients do not respond adequately to levothyroxine, or when rapid T3 elevation is desired. Safety, patient-specific factors, and clinician preference influence decisions.

2. How does the regulatory landscape impact TIROSINT’s market growth?
Regulatory agencies’ safety standards and approval processes affect prescriber confidence. Regulatory guidance cautioning against overuse or high-dose therapy can limit market expansion.

3. What are the primary competitive threats to TIROSINT?
Generic liothyronine products offer lower prices, eroding market share. Additionally, increased use of combination T4/T3 therapy and emerging formulations could reshape prescribing trends.

4. How significant is the role of clinical research in expanding TIROSINT’s market?
Robust clinical trials demonstrating safety, efficacy, and benefits over existing therapies could facilitate broader acceptance and off-label uses, expanding market opportunities.

5. What strategies should manufacturers adopt to enhance TIROSINT’s market position?
Innovating formulations, engaging in clinical research, expanding geographic presence, and navigating reimbursement policies strategically can secure and grow market share.

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References

[1] Market Research Future, Global Thyroid Hormone Market Report, 2023.

[2] IQVIA, Prescribing Data, 2023.

[3] American Thyroid Association, Thyroid Disease Epidemiology, 2021.

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This analysis provides a comprehensive framework for understanding the current market landscape, challenges, and future opportunities for TIROSINT in the global pharmaceutical ecosystem.