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Last Updated: December 27, 2024

THYRO-TABS Drug Patent Profile


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Which patents cover Thyro-tabs, and what generic alternatives are available?

Thyro-tabs is a drug marketed by Alvogen and is included in one NDA.

The generic ingredient in THYRO-TABS 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 Thyro-tabs

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

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Drug patent expirations by year for THYRO-TABS
Pharmacology for THYRO-TABS
Drug Classl-Thyroxine

US Patents and Regulatory Information for THYRO-TABS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alvogen THYRO-TABS levothyroxine sodium TABLET;ORAL 021116-001 Oct 24, 2002 AB1,AB2,AB3,AB4 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alvogen THYRO-TABS levothyroxine sodium TABLET;ORAL 021116-005 Oct 24, 2002 AB1,AB2,AB3,AB4 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alvogen THYRO-TABS levothyroxine sodium TABLET;ORAL 021116-010 Oct 24, 2002 AB1,AB2,AB3,AB4 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

THYRO-TABS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Thyroid Drugs: A Focus on THYRO-TABS and Similar Formulations

Introduction

The market for thyroid drugs, including formulations like THYRO-TABS, is experiencing significant growth driven by several key factors. This article delves into the market dynamics, financial trajectory, and the various elements influencing the demand for these medications.

Rising Prevalence of Thyroid Disorders

Thyroid disorders, such as hypothyroidism, hyperthyroidism, and thyroid nodules, are on the rise globally. This increase is attributed to genetic predisposition, environmental influences, and lifestyle changes, which are fueling the demand for thyroid medications[1].

Global Market Size and Growth

The global injectable thyroid drug market, which includes formulations similar to THYRO-TABS, is projected to grow from USD 439.65 million in 2024 to USD 765.4 million by 2034, at a Compound Annual Growth Rate (CAGR) of 5.7%[1].

Regional Market Dynamics

United States

The United States is a significant market for thyroid drugs, with a CAGR of 4.2% expected during the forecast period. The country's sophisticated healthcare system, specialized professionals, and stringent regulatory framework overseen by the FDA contribute to its high demand for thyroid medications[1].

Europe

Germany is set to lead the European market, with a CAGR of 3.8% by 2034. The country's emphasis on research and development and its stringent regulatory standards are key drivers of this growth[1].

Asia-Pacific

China is experiencing a rapid increase in thyroid disorders due to changing lifestyles and environmental factors, leading to a CAGR of 7.7% during the forecast period. This region is expected to be a significant contributor to the global market[1].

Sales Channels

Hospitals

Hospitals account for a substantial share of the market, with a CAGR of 5.1% expected. They serve as primary healthcare institutions for the diagnosis, treatment, and management of thyroid conditions[1].

Retail Pharmacies

Retail pharmacies are set to lead the sales channel category by 2034. They provide various formulations and brands of thyroid drugs and offer essential services such as medication management and patient education[1].

Key Molecules and Indications

The market for thyroid drugs is driven by key molecules like levothyroxine sodium, liothyronine sodium, and recombinant human TSH. The primary indications include hypothyroidism, hyperthyroidism, and thyroid cancer[1].

Regulatory Framework

The regulatory framework, particularly in the United States and Europe, plays a crucial role in ensuring the safety, efficacy, and quality of thyroid medications. The enforcement of standards such as those set by the United States Pharmacopeia (USP) is a significant driver of the market[3].

Impact of Generic Drugs

The increasing availability and use of generic formulations of levothyroxine sodium are significantly contributing to market growth. Generic drugs offer cost-effective alternatives, making thyroid treatments more accessible to a broader range of patients, especially in developing regions[3].

Innovations and Research

Ongoing developments in pharmaceutical formulations and the growing focus on patient-centric therapies are fueling market growth. Innovations in drug delivery systems, such as extended-release formulations, and improvements in bioavailability and stability are driving demand for advanced APIs[3].

Market Share Analysis

The global levothyroxine sodium market is segmented by region, with North America and Europe dominating due to high levels of healthcare awareness and established pharmaceutical industries. The Asia-Pacific region is expected to experience the fastest growth, driven by rising healthcare expenditures and improved access to medical treatments[3].

Financial Trajectory

Levothyroxine Sodium Market

The global levothyroxine sodium market was valued at USD 3.02 billion in 2023 and is projected to reach USD 4.02 billion by 2032, exhibiting a CAGR of 3.1%[4].

Injectable Thyroid Drug Market

The injectable thyroid drug market is expected to grow from USD 439.65 million in 2024 to USD 765.4 million by 2034, at a CAGR of 5.7%[1].

Challenges and Controversies

The market has faced challenges, including price inflation and regulatory actions. For instance, the UK's Competition and Markets Authority (CMA) fined Advanz Pharma Corp over £100 million for inflating the price of thyroid tablets without any meaningful innovation or investment, highlighting the need for fair pricing practices[5].

Industry Strategies

Leading producers are focusing on collaborations, mergers, distribution agreements, acquisitions, and partnerships to stay competitive. New product launches and developments are key strategies to showcase innovation and scientific advancement[1].

Key Takeaways

  • The global market for thyroid drugs is growing significantly due to the rising prevalence of thyroid disorders.
  • The United States, Germany, and China are key markets with substantial growth potential.
  • Retail pharmacies and hospitals are critical sales channels.
  • Generic formulations and innovations in drug delivery systems are driving market growth.
  • Regulatory frameworks ensure the quality and safety of thyroid medications.
  • Fair pricing practices are essential to avoid regulatory actions.

FAQs

What is the projected growth rate of the global injectable thyroid drug market?

The global injectable thyroid drug market is projected to grow at a CAGR of 5.7% from 2024 to 2034[1].

Which regions are expected to lead the market growth for thyroid drugs?

The United States, Germany, and China are expected to be significant contributors to the global market growth for thyroid drugs[1].

What role do generic formulations play in the thyroid drug market?

Generic formulations offer cost-effective alternatives, making thyroid treatments more accessible to a broader range of patients, especially in developing regions[3].

How do regulatory standards impact the thyroid drug market?

Regulatory standards, such as those set by the USP, ensure the quality, purity, and consistency of thyroid medications, driving demand for high-quality APIs[3].

What are the key molecules and indications for thyroid drugs?

The key molecules include levothyroxine sodium, liothyronine sodium, and recombinant human TSH, with primary indications being hypothyroidism, hyperthyroidism, and thyroid cancer[1].

Sources

  1. Future Market Insights: Injectable Thyroid Drug Market Share, Trend & Forecast 2034
  2. Amneal: Amneal Announces 10-Year Licensing and Supply Agreement with Jerome Stevens Pharmaceuticals Inc. for Levothyroxine
  3. PR Newswire: Levothyroxine Sodium API Market Size to Grow USD 42 Million by 2030 at a CAGR of 4.5%
  4. Business Research Insights: Levothyroxine Sodium Market Size, Share & Forecast, 2032
  5. GOV.UK: CMA fines pharma firm over pricing of crucial thyroid drug

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