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Last Updated: December 26, 2024

EUTHYROX Drug Patent Profile


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When do Euthyrox patents expire, and when can generic versions of Euthyrox launch?

Euthyrox is a drug marketed by Provell and is included in one NDA.

The generic ingredient in EUTHYROX 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 Euthyrox

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

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Summary for EUTHYROX
Drug patent expirations by year for EUTHYROX
Drug Prices for EUTHYROX

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Recent Clinical Trials for EUTHYROX

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

SponsorPhase
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyPhase 1
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Zhejiang Provincial Hospital of TCMPhase 4

See all EUTHYROX clinical trials

Pharmacology for EUTHYROX
Drug Classl-Thyroxine

US Patents and Regulatory Information for EUTHYROX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Provell EUTHYROX levothyroxine sodium TABLET;ORAL 021292-001 May 31, 2002 AB2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Provell EUTHYROX levothyroxine sodium TABLET;ORAL 021292-007 May 31, 2002 AB2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Provell EUTHYROX levothyroxine sodium TABLET;ORAL 021292-004 May 31, 2002 AB2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Provell EUTHYROX levothyroxine sodium TABLET;ORAL 021292-012 May 31, 2002 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Provell EUTHYROX levothyroxine sodium TABLET;ORAL 021292-008 May 31, 2002 AB2 RX No 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

EUTHYROX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Euthyrox

Introduction to Euthyrox

Euthyrox, a brand name for levothyroxine, is a synthetic form of the thyroid hormone thyroxine (T4), used primarily to treat hypothyroidism and pituitary TSH suppression. Here, we delve into the market dynamics and financial trajectory of Euthyrox, a key player in the global levothyroxine market.

Global Levothyroxine Market Overview

The global levothyroxine market is projected to grow significantly, driven by the increasing incidence of thyroid disorders worldwide. As of 2024, the global levothyroxine market size is estimated at USD 3951.2 million, with a forecasted compound annual growth rate (CAGR) of 3.50% from 2024 to 2031, reaching USD 5027.029823 million by 2031[1].

Regional Market Share

  • North America: This region holds a significant market share, with USD 1580.48 million in 2024 and a CAGR of 1.7% from 2024 to 2031. The United States is the largest market within North America, with sales revenue of USD 1247 million in 2024 and a CAGR of 1.5%[1].
  • Europe: Europe accounts for over 30% of the global revenue, with a market size of USD 1185.36 million in 2024 and a CAGR of 2% from 2024 to 2031. Countries like Germany and the UK contribute substantially to this growth[1].
  • Asia-Pacific: This region is expected to see the highest CAGR of 5.5% from 2024 to 2031, driven by improving healthcare infrastructure in countries like China and India[1].

Market Drivers

  • Increasing Incidence of Thyroid Disorders: The rising prevalence of thyroid disorders globally is a primary driver for the growth of the levothyroxine market[1].
  • Improving Healthcare Infrastructure: Especially in the Asia-Pacific region, better access to diagnosis and treatment options is boosting demand for levothyroxine[1].
  • Generic and Branded Market Dynamics: The U.S. brand and generic market for levothyroxine sodium tablets is estimated to be approximately $2.6 billion in annual sales, with over 122 million annual prescriptions[3].

Financial Performance of Key Players

Merck KGaA

Merck KGaA, the manufacturer of Euthyrox, has shown strong financial performance in recent years. In the second quarter of 2022, Merck's Healthcare business sector reported organic sales growth of 1.4%, with net sales increasing by 7.6% to € 1,924 million. This growth was partly driven by new products, including Euthyrox[2].

  • Revenue Growth: Merck's overall net sales increased by 14.3% to € 5.6 billion in the second quarter of 2022, with EBITDA pre rising by 13.1% to € 1.8 billion[2].
  • Cost and Pricing Strategies: Despite cost inflation, Merck has managed to offset these costs through price increases, contributing to improved margins[2].

Amneal Pharmaceuticals

Amneal Pharmaceuticals, another significant player in the levothyroxine market, has entered into a 10-year licensing and supply agreement with Jerome Stevens Pharmaceuticals for levothyroxine. This agreement includes an upfront milestone payment and a profit share on future sales, indicating a long-term commitment to the market[3].

Innovative Business Models

Direct-to-Consumer Model

Provell Pharmaceuticals, in partnership with Mark Cuban's Cost Plus Drug Company, has introduced a direct-to-consumer model for Euthyrox. This model aims to offer prescription drugs at significantly lower costs by reducing overheads and increasing transparency in pricing. This approach is gaining traction and could disrupt traditional pharmaceutical pricing models[4].

Key Challenges and Opportunities

  • Manufacturing and Validation Challenges: Levothyroxine production is known for its complexity, which can affect market supply and quality. Companies like Amneal and Merck have to navigate these challenges to maintain market share[3].
  • Generic Competition: The presence of generic levothyroxine products poses a challenge to branded drugs like Euthyrox. However, branded drugs often maintain market share through brand loyalty and quality perceptions[3].

Future Outlook

The future of Euthyrox and the broader levothyroxine market looks promising, driven by increasing demand and innovative business models.

  • Investments in Innovation: Companies like Merck are investing significantly in innovation and capacities, which will further drive growth in the healthcare sector, including the levothyroxine market[5].
  • Geographical Expansion: The Asia-Pacific region, with its growing healthcare infrastructure, presents a significant opportunity for expansion and growth[1].

Key Takeaways

  • Growing Market Size: The global levothyroxine market is expected to grow from USD 3951.2 million in 2024 to USD 5027.029823 million by 2031.
  • Regional Growth: North America, Europe, and Asia-Pacific are key regions driving market growth.
  • Innovative Business Models: Direct-to-consumer models and cost-effective pricing strategies are changing the market dynamics.
  • Challenges and Opportunities: Manufacturing complexities and generic competition are challenges, while investments in innovation and geographical expansion offer opportunities.

FAQs

  1. What is the current market size of the global levothyroxine market?

    • The global levothyroxine market size is estimated at USD 3951.2 million in 2024[1].
  2. What is the projected CAGR for the global levothyroxine market from 2024 to 2031?

    • The projected CAGR is 3.50% from 2024 to 2031[1].
  3. Which region has the highest CAGR for the levothyroxine market?

    • The Asia-Pacific region has the highest CAGR of 5.5% from 2024 to 2031[1].
  4. How does the direct-to-consumer model impact the pricing of Euthyrox?

    • The direct-to-consumer model significantly reduces the cost of Euthyrox by eliminating traditional overheads and increasing pricing transparency[4].
  5. What are the key drivers for the growth of the levothyroxine market?

    • The key drivers include the increasing incidence of thyroid disorders and improving healthcare infrastructure, especially in the Asia-Pacific region[1].

Sources

  1. Cognitive Market Research: Levothyroxine Market Report 2024 (Global Edition)
  2. Merck KGaA: Half-Yearly Financial Report Q2/2022
  3. Amneal Pharmaceuticals: Amneal Announces 10-Year Licensing and Supply Agreement with Jerome Stevens Pharmaceuticals Inc. for Levothyroxine
  4. Provell Pharmaceuticals and Mark Cuban Cost Plus Drug Company: Provell Pharmaceuticals and Mark Cuban Cost Plus Drug Company Bring Leading Hypothyroid Drug Euthyrox to US Patients at Low-Cost Prices
  5. EMD Group: Annual Financial Statements - 2021

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