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Last Updated: December 22, 2024

SYNTHROID Drug Patent Profile


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When do Synthroid patents expire, and what generic alternatives are available?

Synthroid is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in SYNTHROID is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Synthroid

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

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Drug patent expirations by year for SYNTHROID
Drug Prices for SYNTHROID

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Drug Sales Revenue Trends for SYNTHROID

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Recent Clinical Trials for SYNTHROID

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SponsorPhase
VA Office of Research and DevelopmentPhase 2
VA Office of Research and DevelopmentPhase 4
Central Arkansas Veterans Healthcare SystemPhase 4

See all SYNTHROID clinical trials

Pharmacology for SYNTHROID
Drug Classl-Thyroxine

US Patents and Regulatory Information for SYNTHROID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie SYNTHROID levothyroxine sodium TABLET;ORAL 021402-001 Jul 24, 2002 AB1,AB2 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie SYNTHROID levothyroxine sodium TABLET;ORAL 021402-007 Jul 24, 2002 AB1,AB2 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie SYNTHROID levothyroxine sodium TABLET;ORAL 021402-004 Jul 24, 2002 AB1,AB2 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie SYNTHROID levothyroxine sodium TABLET;ORAL 021402-011 Jul 24, 2002 AB1,AB2 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie SYNTHROID levothyroxine sodium TABLET;ORAL 021402-008 Jul 24, 2002 AB1,AB2 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SYNTHROID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Levothyroxine (Synthroid)

Market Overview

Levothyroxine, commonly known by the brand name Synthroid, is a synthetic form of the thyroid hormone thyroxine (T4), used to treat hypothyroidism and other thyroid disorders. The market for levothyroxine has been steadily growing, driven by several key factors.

Market Size and Growth

As of 2023, the levothyroxine market was valued at approximately $3.8 billion[1][3][4].

  • It is projected to grow at a compound annual growth rate (CAGR) of 3.3% to 4.5% from 2024 to 2034, reaching a market size of around $5.4 billion by 2034[1][3].

Regional Dominance

North America

North America dominates the levothyroxine market, largely due to the growing awareness of thyroid disorders among the U.S. population. According to the American Thyroid Association, about 12% of the U.S. population is expected to suffer from thyroid disorders at some stage in their lives, with 20 million Americans already affected[1].

Europe

Europe also holds a significant share, primarily driven by the higher prevalence of thyroid disorders among the elderly population[1].

Asia Pacific

The Asia Pacific region, led by China, is another key market. This region is expected to see substantial growth due to increasing healthcare expenditure and a growing awareness of thyroid health[1][3].

Distribution Channels

The market is segmented by distribution channels, with hospital pharmacies accounting for the largest share in 2023. Retail pharmacies and online pharmacies also play significant roles, with the latter expected to grow as telemedicine and e-pharmacy services become more prevalent[1][3].

Drivers of Growth

Increasing Prevalence of Thyroid Disorders

The escalating severity of thyroid disorders, including hypothyroidism and thyroid cancer, is a major driver. For instance, the American Cancer Society predicts approximately 44,020 new cases of thyroid cancer in the U.S. by 2024[3].

Enhanced Awareness and Recognition

Increased awareness and recognition of hypothyroidism, along with rigorous clinical trials and research demonstrating the safety and efficacy of levothyroxine sodium, contribute to market growth[3].

Generic Formulations and Health Insurance

The introduction of generic formulations offering cost-effective alternatives and expanded health insurance coverage for prescription medications also drive the market[3].

Sustainable Healthcare Practices

There is an increasing focus on sustainable healthcare practices, which includes the production, distribution, and disposal of levothyroxine sodium products. This trend is expected to impact the market positively[3].

Competitive Landscape

The levothyroxine market is highly competitive, with several key players:

  • AbbVie Inc.: Known for its robust pipeline programs targeting various conditions, AbbVie continues to strengthen its position in the market[1].
  • Mylan N.V.
  • Merck & Co., Inc.
  • Pfizer Inc.
  • Lannett Company Inc
  • Novartis AG
  • Fresenius Kabi
  • Piramal Critical Care
  • Abbott Laboratories

These companies are continuously working on upgrading their product portfolios and expanding their market reach[1].

Financial Performance of Key Players

AbbVie

AbbVie, one of the major players, reported full-year net revenues of $54.318 billion in 2023, with a decrease of 6.4% on a reported basis. Despite this, AbbVie's immunology portfolio, which includes some thyroid-related treatments, remains strong. The company is also investing heavily in R&D and has announced significant acquisitions to bolster its pipeline[2].

Market Attractiveness Analysis

By Route of Administration

The market is segmented by route of administration, with oral formulations being the dominant form. Injectable forms also exist but are less common[1][4].

By Distribution Channel

Hospital pharmacies remain the most attractive distribution channel, followed by retail and online pharmacies. The attractiveness of online pharmacies is expected to increase with the growth of telemedicine and e-pharmacy services[1][3].

By Region

North America remains the most attractive region due to its large patient base and high awareness of thyroid disorders. Europe and Asia Pacific also offer significant opportunities due to their growing healthcare needs and increasing prevalence of thyroid conditions[1][3].

Challenges and Restraints

Competition from Biosimilars

The market faces competition from biosimilars, particularly in regions where generic formulations are more prevalent. This competition can affect the market share of branded products like Synthroid[1].

Regulatory and Quality Standards

Stringent quality assurance standards and regulatory requirements can pose challenges for manufacturers. Compliance with these standards is crucial for maintaining market presence[3].

Economic Factors

Higher inflation and interest rates, as well as the impact of global events like the Russian-Ukraine war, can affect the overall economy and subsequently the healthcare market. These factors can influence the demand and supply chain of levothyroxine sodium products[3].

Future Trends

Innovations in Laboratory Formulations

Advancements in laboratory formulations and the introduction of new products are expected to drive market growth. Innovations in organ transplantation research and telemedicine services will also play a significant role[3].

Patient-Centered Care Models

There is a shift towards patient-centered care models, which emphasizes personalized treatment plans. This trend is expected to increase the demand for levothyroxine sodium as it aligns with the need for tailored healthcare solutions[3].

Environmental Factors

Heightened awareness of environmental factors influencing thyroid health will also contribute to the market's growth. This includes understanding how environmental changes can impact thyroid function and the need for thyroid hormone supplements[3].

"The levothyroxine sodium market is poised for growth due to escalating severity of thyroid disorders. These conditions affect the thyroid gland, located in the neck's front, and their severity stems from factors such as delayed diagnosis, inadequate treatment, autoimmune reactions, or complications from other medical conditions."[3]

Key Takeaways

  • The levothyroxine market is valued at $3.8 billion in 2023 and is expected to grow to $5.4 billion by 2034.
  • North America dominates the market due to high awareness and prevalence of thyroid disorders.
  • Hospital pharmacies are the largest distribution channel, but online pharmacies are growing.
  • Key drivers include increasing prevalence of thyroid disorders, enhanced awareness, and generic formulations.
  • Major players like AbbVie are investing heavily in R&D and expanding their product portfolios.
  • The market faces challenges from biosimilars and regulatory standards but is expected to grow with innovations in laboratory formulations and patient-centered care models.

FAQs

What is the current market size of the levothyroxine market?

The levothyroxine market was valued at approximately $3.8 billion in 2023[1].

Which region dominates the levothyroxine market?

North America dominates the levothyroxine market, primarily due to the growing awareness of thyroid disorders in the U.S.[1].

What are the key drivers of the levothyroxine market?

Key drivers include the increasing prevalence of thyroid disorders, enhanced awareness and recognition of hypothyroidism, rigorous clinical trials, and the introduction of generic formulations[3].

Who are the major players in the levothyroxine market?

Major players include AbbVie Inc., Mylan N.V., Merck & Co., Inc., Pfizer Inc., Lannett Company Inc, Novartis AG, Fresenius Kabi, Piramal Critical Care, and Abbott Laboratories[1].

What are the expected future trends in the levothyroxine market?

Future trends include innovations in laboratory formulations, advancements in organ transplantation research, increased adoption of telemedicine and e-pharmacy services, and a shift towards patient-centered care models[3].

How does the economic environment impact the levothyroxine market?

Higher inflation, interest rates, and global events like the Russian-Ukraine war can affect the overall economy and subsequently the healthcare market, influencing the demand and supply chain of levothyroxine sodium products[3].

Sources

  1. Transparency Market Research: Levothyroxine Market Size, Share, Analysis to 2034.
  2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
  3. GII Research: Levothyroxine Sodium Global Market Report 2024.
  4. Market Research Future: Levothyroxine Sodium Market Size, Share Trends Report 2032.

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