LIOTHYRONINE SODIUM Drug Patent Profile

Which patents cover Liothyronine Sodium, and when can generic versions of Liothyronine Sodium launch?

Liothyronine Sodium is a drug marketed by Xgen Pharms, Biocon Pharma, Dr Reddys Labs Sa, Pharmobedient, Sigmapharm Labs Llc, Sun Pharm, Teva Pharms Usa, Watson Labs, and Zydus Lifesciences. and is included in ten NDAs.

The generic ingredient in LIOTHYRONINE SODIUM is liothyronine sodium. There are four drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the liothyronine sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Liothyronine Sodium

A generic version of LIOTHYRONINE SODIUM was approved as liothyronine sodium by XGEN PHARMS on August 17^th, 2005.

Summary for LIOTHYRONINE SODIUM

US Patents:	0
Applicants:	9
NDAs:	10
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	15
Patent Applications:	1,502
What excipients (inactive ingredients) are in LIOTHYRONINE SODIUM?	LIOTHYRONINE SODIUM excipients list
DailyMed Link:	LIOTHYRONINE SODIUM at DailyMed

Recent Clinical Trials for LIOTHYRONINE SODIUM

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

Sponsor	Phase
University of Minnesota - Clinical and Translational Science Institute	Phase 1/Phase 2
University of Minnesota	Phase 1/Phase 2
Aultman Health Foundation	Phase 2

See all LIOTHYRONINE SODIUM clinical trials

Pharmacology for LIOTHYRONINE SODIUM

Drug Class

l-Triiodothyronine

Anatomical Therapeutic Chemical (ATC) Classes for LIOTHYRONINE SODIUM

H03AA	Thyroid hormones
H03A	THYROID PREPARATIONS
H03	THYROID THERAPY
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for LIOTHYRONINE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xgen Pharms	LIOTHYRONINE SODIUM	liothyronine sodium	INJECTABLE;INJECTION	076923-001	Aug 17, 2005		RX	No	Yes
Teva Pharms Usa	LIOTHYRONINE SODIUM	liothyronine sodium	TABLET;ORAL	211510-002	Oct 26, 2018	AB	RX	No	No
Zydus Lifesciences	LIOTHYRONINE SODIUM	liothyronine sodium	TABLET;ORAL	214803-003	Jan 22, 2021	AB	RX	No	No
Dr Reddys Labs Sa	LIOTHYRONINE SODIUM	liothyronine sodium	TABLET;ORAL	090097-003	Mar 20, 2009	AB	RX	No	No

Market Dynamics and Financial Trajectory for Liothyronine Sodium

Last updated: March 18, 2026

Liothyronine sodium, a synthetic form of triiodothyronine (T3), is primarily prescribed for hypothyroidism and certain thyroid cancer treatments. Its market outlook is shaped by regulatory, clinical, and competitive factors, with a steadily growing demand driven by emerging indications and market penetration trends.

Market Overview

Liothyronine sodium holds a significant position within thyroid hormone replacement therapies. The drug’s sales are influenced by endocrinology treatment patterns, regulatory approvals, and patent statuses. The global market size was valued at approximately USD 200 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of about 5-7% over the next five years.

Key Market Drivers

• Rising prevalence of hypothyroidism: An estimated 5% of the population globally has hypothyroidism, with higher rates in women aged 30-50.
• Shifts towards personalized medicine: Increased use of T3-based therapies for specific hypothyroidism subtypes and thyroid cancer management.
• New formulations and delivery methods: Development of sustained-release formulations position the drug as an alternative to levothyroxine, which dominates the market.

Market Challenges

• Limited patent protection: Many formulations are off-patent, leading to price competition.
• Safety concerns: Potential risks linked to T3 overdose, including cardiac arrhythmias, limit broad adoption.
• Regulatory shifts: Stringent approval processes in major markets (e.g., FDA, EMA) affect launch timelines and market access.

Competitive Landscape

Major players include:

Company	Product Details	Market Share	Notes
JCD (Johnson & Johnson division)	Synthroid (levothyroxine), Liothyronine	Approximately 60%	Dominates hypothyroidism treatments; liothyronine sales are smaller but growing
GB Pharmaceuticals	Generic liothyronine sodium products	15-20%	Significant in emerging markets
Other Generic Makers	Various formulations	15-25%	Price competition affects margins

Patent expirations for several formulations have increased generic availability, lowering prices and squeezing margins for branded products. Recent innovations focus on sustained-release formulations for better symptom control.

Regulatory and Policy Environment

• The US FDA considers liothyronine sodium’s safety profile, with approvals requiring evidence for both efficacy and safety.
• The EMA emphasizes pharmacovigilance, especially concerning cardiovascular risks.
• Market expansion in developing countries is expected as regulatory agencies standardize thyroid disorder management.

Financial Trajectory

Revenue Trends

Year	Estimated Sales (USD millions)	Growth Rate	Key Notes
2022	200	Baseline	Market size established
2023	210	5%	Slight market growth
2024	220	5%	Increased clinical use
2025	235	7%	Market expansion in Asia

Investment and R&D

• Investment centers around new formulations, with R&D budgets ranging between 10-15% of sales for key companies.
• Regulatory approval of extended-release versions in the US and Europe could spur sales growth by offering improved patient compliance.

Price Dynamics

• Average current prices for branded liothyronine sodium range from USD 2 to 4 per pill.
• In markets with generic competition, prices fall below USD 1 per pill.
• Price erosion is expected to continue, driven by increasing generic penetration.

Strategic Considerations

• Market entry requires navigating regulatory hurdles and ensuring safety profile differentiation.
• Focus on developing formulations with improved bioavailability and reduced cardiovascular risks.
• Expansion into less mature markets (e.g., Brazil, India) offers growth opportunities, given increasing diagnosis rates.

Key Takeaways

Liothyronine sodium’s market is characterized by moderate growth, driven by hypothyroidism prevalence and product innovation. Patent expiries have increased generic competition, pressuring prices and margins. Regulatory scrutiny regarding safety influences uptake and formulation development. Industry players focus on new delivery systems to differentiate their portfolios, with emerging markets representing future growth avenues.

5 FAQs

1. Is liothyronine sodium patent-protected?
Most formulations are off-patent, leading to widespread generic competition.

2. What factors influence sales growth?
Prevalence of hypothyroidism, regulatory approvals, formulation innovations, and market expansion influence growth.

3. How are safety concerns affecting market prospects?
Risks of cardiac side effects limit broad use and encourage development of safer formulations.

4. Which regions are most promising for expansion?
Emerging markets such as Asia and South America have growing diagnosis rates and regulatory frameworks improving market access.

5. What is the future outlook for liothyronine sodium prices?
Prices are likely to decline due to generic competition but may stabilize if new, more effective formulations gain approval.

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References

[1] Market research estimates based on industry reports (2022-2023).
[2] Regulatory guidelines from the U.S. Food and Drug Administration (FDA).
[3] European Medicines Agency (EMA) policy documents.