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Last Updated: April 23, 2025

Liotrix (t4;t3) - Generic Drug Details


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What are the generic sources for liotrix (t4;t3) and what is the scope of freedom to operate?

Liotrix (t4;t3) is the generic ingredient in ten branded drugs marketed by Parke Davis and Allergan, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for liotrix (t4;t3)
US Patents:0
Tradenames:10
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 11
Patent Applications: 896
DailyMed Link:liotrix (t4;t3) at DailyMed

US Patents and Regulatory Information for liotrix (t4;t3)

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Parke Davis EUTHROID-0.5 liotrix (t4;t3) TABLET;ORAL 016680-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Allergan THYROLAR-0.25 liotrix (t4;t3) TABLET;ORAL 016807-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Allergan THYROLAR-3 liotrix (t4;t3) TABLET;ORAL 016807-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  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
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Liotrix (T4; T3)

Introduction to Liotrix

Liotrix is a synthetically derived thyroid hormone replacement preparation, consisting of levothyroxine sodium (thyroxine, T4) and liothyronine sodium (triiodothyronine, T3) in a 4 to 1 ratio by weight. This combination is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones[4].

Market Drivers

Increasing Prevalence of Thyroid Disorders

The global market for thyroid hormone replacement therapies, including liotrix, is driven by the rising prevalence of thyroid disorders such as hypothyroidism. According to the National Institute of Health, hypothyroidism affects around 5% of individuals worldwide each year, with a significant portion of the population remaining undiagnosed[1].

Lifestyle and Environmental Factors

Changes in lifestyle and environmental influences are contributing to the increasing incidence of thyroid disorders. Unhealthy diets and modified lifestyles are key factors exacerbating thyroid-related conditions, thereby increasing the demand for treatments like liotrix[1][2].

Advancements in Treatment Options

Pharmaceutical companies are focusing on advancements in the treatment of thyroid-related conditions. For instance, the development of sustained-release dosage forms, such as Titan Pharmaceuticals' ProNeura sub-dermal implant, is expected to drive the market growth for liotrix and other thyroid hormone replacement therapies[1].

Market Segmentation

By Product Type

The market for liotrix is segmented based on the type of product, which includes combination hormone replacement therapies like liotrix, as well as single hormone therapies such as levothyroxine sodium and liothyronine sodium. Liotrix, being a combination therapy, caters to a specific segment of patients who require both T4 and T3 hormones[4].

By Indication

The primary indication for liotrix is hypothyroidism, although it can also be used for other thyroid-related conditions. The market is segmented based on these indications, with hypothyroidism being the leading segment[2].

By Distribution Channel

The distribution channels for liotrix include hospitals, specialty clinics, retail pharmacies, and mail-order pharmacies. Hospital pharmacies and retail pharmacies are the leading distribution channels, accounting for a significant share of the market[2].

By Region

The global market for liotrix is segmented into regions such as North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America, particularly the U.S., dominates the market due to high awareness and prevalence of thyroid disorders[1][5].

Financial Trajectory

Market Size and Growth

The global injectable thyroid drug market, which includes liotrix, is projected to grow at a CAGR of 5.7% from 2024 to 2034, reaching from USD 439.65 million in 2024 to USD 765.4 million by 2034[2].

Revenue Projections

  • 2023: The injectable thyroid drug market was valued at USD 414.4 million.
  • 2024: The market is projected to be USD 439.65 million.
  • 2034: The market is expected to reach USD 765.4 million[2].

Key Molecules

Liothyronine sodium, a component of liotrix, is expected to grow at a CAGR of 5.4% from 2024 to 2034, which is slightly higher than the growth rate of levothyroxine sodium at 5.1%[2].

Competitive Landscape

Key Players

The market for liotrix and other thyroid hormone replacement therapies is competitive, with key players including ITL Pharma, Inc., Bioiberica S.A.U, Titan Pharmaceuticals, Inc., Genzyme Corporation (Sanofi), Fresenius Kabi, and XGEN PHARMACEUTICALS DJB, Inc. These companies are focusing on product approvals, launches, and strategic collaborations to strengthen their market share[1][2].

Strategic Initiatives

Companies are engaging in various strategic initiatives such as collaborations, mergers, distribution agreements, acquisitions, and partnerships to stay competitive. New product launches and developments are also a key focus area, reflecting the industry's commitment to innovation and addressing evolving demands[2].

Challenges and Restraints

COVID-19 Impact

The COVID-19 pandemic has negatively impacted the global liotrix market. Lockdowns and bans on non-urgent surgical treatments have resulted in difficulties for patients in undergoing regular thyroid function tests and receiving necessary treatments. This has temporarily slowed the market growth[1].

Regulatory and Safety Concerns

There are ongoing concerns regarding the potency and safety of thyroid hormone replacement therapies. For instance, levothyroxine sodium pentahydrate tablets have faced recalls due to sub-potency issues, which can affect market confidence and growth[3].

Future Outlook

Growing Demand in Emerging Markets

The growing healthcare infrastructure in countries like China is expected to improve the diagnosis, treatment, and management of thyroid disorders, driving the demand for liotrix and other thyroid hormone replacement therapies in these regions[2].

Innovations in Delivery Systems

Advancements in delivery systems, such as sustained-release dosage forms, are expected to enhance patient compliance and treatment outcomes, further driving the market growth for liotrix and similar products[1].

Key Takeaways

  • Increasing Prevalence: The rising prevalence of thyroid disorders is a significant driver for the liotrix market.
  • Market Growth: The global injectable thyroid drug market, including liotrix, is projected to grow at a CAGR of 5.7% from 2024 to 2034.
  • Competitive Landscape: Key players are focusing on strategic initiatives and product innovations to maintain market share.
  • Challenges: The COVID-19 pandemic and regulatory concerns are temporary restraints on the market.
  • Future Outlook: Growing demand in emerging markets and innovations in delivery systems are expected to drive future growth.

FAQs

What is liotrix used for?

Liotrix is used as a thyroid hormone replacement therapy, primarily for the treatment of hypothyroidism. It is a combination of levothyroxine sodium (T4) and liothyronine sodium (T3)[4].

How is the liotrix market segmented?

The liotrix market is segmented by product type, indication, distribution channel, and region. The primary indication is hypothyroidism, and key distribution channels include hospitals, specialty clinics, and retail pharmacies[1][2].

What is the projected growth rate for the liotrix market?

The global injectable thyroid drug market, which includes liotrix, is projected to grow at a CAGR of 5.7% from 2024 to 2034[2].

Who are the key players in the liotrix market?

Key players include ITL Pharma, Inc., Bioiberica S.A.U, Titan Pharmaceuticals, Inc., Genzyme Corporation (Sanofi), Fresenius Kabi, and XGEN PHARMACEUTICALS DJB, Inc.[1][2].

How has the COVID-19 pandemic affected the liotrix market?

The COVID-19 pandemic has negatively impacted the market due to lockdowns and bans on non-urgent surgical treatments, making it difficult for patients to undergo regular thyroid function tests and receive necessary treatments[1].

Sources

  1. Coherent Market Insights: Liothyronine Market Size, Trends And Forecast To 2028.
  2. Future Market Insights: Injectable Thyroid Drug Market Share, Trend & Forecast 2034.
  3. Journal of Pharmaceutical Sciences: Levothyroxine Sodium Pentahydrate Tablets.
  4. DrugBank Online: Liotrix: Uses, Interactions, Mechanism of Action.
  5. Transparency Market Research: Levothyroxine Market Size, Share, Analysis to 2034.

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