LEVOXYL Drug Patent Profile

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

Levoxyl is a drug marketed by King Pharms and is included in one NDA.

The generic ingredient in LEVOXYL 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 Levoxyl

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

Summary for LEVOXYL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	1
Patent Applications:	4,345
Drug Prices:	Drug price information for LEVOXYL
Drug Sales Revenues:	Drug sales revenues for LEVOXYL
What excipients (inactive ingredients) are in LEVOXYL?	LEVOXYL excipients list
DailyMed Link:	LEVOXYL at DailyMed

See drug prices for LEVOXYL

See drug sales revenues for LEVOXYL

Recent Clinical Trials for LEVOXYL

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A
Children's Hospital of Philadelphia	N/A

See all LEVOXYL clinical trials

Pharmacology for LEVOXYL

Drug Class

l-Thyroxine

US Patents and Regulatory Information for LEVOXYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-001	May 25, 2001	AB1,AB3	RX	Yes	No
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-007	May 25, 2001	AB1,AB3	RX	Yes	No
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-004	May 25, 2001	AB1,AB3	RX	Yes	No
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-012	May 25, 2001		DISCN	Yes	No

Expired US Patents for LEVOXYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-012	May 25, 2001	6,555,581
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-009	May 25, 2001	7,101,569
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-003	May 25, 2001	6,555,581
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-006	May 25, 2001	7,101,569

International Patents for LEVOXYL

See the table below for patents covering LEVOXYL around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2438907
Mexico	PA03007337	COMPOSICION FARMACEUTICA Y DE HORMONA TIROIDEA ESTABILIZADA Y METODO DE PREPARACION DE LA MISMA. (STABILIZED PHARMACEUTICAL AND THYROID HORMONE COMPOSITIONS AND METHOD OF PREPARATION.)
Australia	2002332507
Brazil	0207299

LEVOXYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Levothyroxine (LEVOXYL)

Market Overview

Levothyroxine, commonly known by brand names such as LEVOXYL, is a synthetic form of the thyroid hormone thyroxine (T4), used primarily to treat hypothyroidism and other thyroid disorders. The global market for levothyroxine is experiencing significant growth driven by several key factors.

Global Market Size and Growth

As of 2024, the global levothyroxine market is estimated to be valued at USD 3.95 billion[1][4].

• This market is projected to grow at a compound annual growth rate (CAGR) of 3.3% to 3.5% from 2024 to 2031, reaching approximately USD 5.0 billion to USD 5.4 billion by the end of the forecast period[1][4].

Regional Market Analysis

North America

• North America holds a significant share of the global levothyroxine market, with an estimated market size of USD 1.58 billion in 2024. It is expected to grow at a CAGR of 1.7% from 2024 to 2031[1].
• The United States is the largest market within North America, with a market size of USD 1.25 billion in 2024 and a CAGR of 1.5% during the forecast period[1].

Europe

• Europe accounts for around 30% of the global revenue, with a market size of USD 1.19 billion in 2024. It is expected to grow at a CAGR of 2.2% from 2024 to 2031[1].

Asia-Pacific

• The Asia-Pacific region is expected to see the highest growth, with a market size of USD 908.78 million in 2024 and a CAGR of 5.5% from 2024 to 2031. This growth is driven by improving healthcare infrastructure in countries like China and India[1].

Latin America and Middle East & Africa

• Latin America holds around 5% of the global market share, with a market size of USD 197.56 million in 2024 and a CAGR of 2.9% from 2024 to 2031[1].
• The Middle East & Africa region also shows promising growth, with the GCC countries expected to grow at a CAGR of 4% during the forecast period[1].

Market Drivers

Rising Prevalence of Thyroid Disorders

• The increasing incidence of thyroid disorders globally is a major driver for the levothyroxine market. Hypothyroidism, in particular, is becoming more prevalent, leading to higher demand for levothyroxine[2][4].

Growing Healthcare Expenditure

• Increased healthcare expenditure, especially in emerging economies, is contributing to the growth of the levothyroxine market. Better access to healthcare services and diagnostic facilities is enhancing the detection and treatment of thyroid disorders[2][4].

Generic Formulations and Cost-Effectiveness

• The introduction of generic levothyroxine formulations has provided cost-effective alternatives, making the treatment more accessible to a wider population. This has significantly boosted the market growth[2].

Advanced Formulations and Research

• Continuous research and development in the field of thyroid treatments, including advanced formulations and new product introductions, are also driving the market forward[2].

Market Restraints

Regulatory Challenges

• Strict regulatory requirements and the need for rigorous clinical trials can act as restraints for new entrants in the market. Compliance with quality assurance standards is also a challenge[2].

Environmental Factors

• Heightened awareness of environmental factors affecting thyroid health can sometimes lead to fluctuations in demand, as patients may seek alternative treatments or lifestyle changes[2].

Market Segmentation

By Product

• The market is segmented into oral and injectable forms of levothyroxine. Oral formulations dominate the market due to their ease of administration and higher patient compliance[2][4].

By Application

• The primary applications include hospitals, clinics, and other healthcare settings. Hospital pharmacies account for the largest share due to the high volume of prescriptions filled in these settings[2][4].

By Distribution Channel

• The distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies hold the largest market share due to the direct prescription fulfillment process[4].

Competitive Landscape

The levothyroxine market is highly competitive with several key players:

• AbbVie Inc.
• Mylan N.V.
• Merck & Co., Inc.
• Pfizer Inc.
• Lannett Company Inc.
• Novartis AG
• Fresenius Kabi
• Piramal Critical Care
• Abbott Laboratories[4].

Financial Trajectory

Revenue Forecast

• The global levothyroxine market is expected to reach USD 5.0 billion to USD 5.4 billion by 2031, growing at a CAGR of 3.3% to 3.5% from 2024 to 2031[1][4].

Regional Revenue

• North America: USD 1.58 billion in 2024, growing at a CAGR of 1.7%[1].
• Europe: USD 1.19 billion in 2024, growing at a CAGR of 2.2%[1].
• Asia-Pacific: USD 908.78 million in 2024, growing at a CAGR of 5.5%[1].

Segment-wise Growth

• Oral formulations are expected to continue dominating the market due to their widespread use and patient compliance.
• Hospital pharmacies will remain the largest distribution channel due to the high volume of prescriptions[4].

Key Trends

Patient-Centered Care Models

• There is a shift towards patient-centered care models, which emphasize personalized treatment plans, including the use of levothyroxine tailored to individual patient needs[2].

Telemedicine and E-Pharmacy

• The rise of telemedicine and e-pharmacy services is making levothyroxine more accessible, especially in remote or underserved areas[2].

Sustainable Healthcare Practices

• Increasing focus on sustainable healthcare practices is influencing the production, distribution, and disposal of levothyroxine products, driving innovation in the market[2].

Economic Impact

Productivity and Healthcare Costs

• Patients with thyroid disorders who require dose adjustments experience significant economic impacts, including increased healthcare costs and lost productivity. For instance, patients with at least one dose adjustment experienced a 40.3% increase in lost productivity compared to those with no dose adjustments[5].

"Patients with at least one dose adjustment experienced a 40.3% increase in lost productivity vs. patients who had no dose adjustments (US$1381 vs. US$984)" - PubMed[5].

Key Takeaways

• The global levothyroxine market is projected to grow significantly due to the rising incidence of thyroid disorders and improvements in healthcare infrastructure.
• North America and Europe are major markets, but Asia-Pacific is expected to see the highest growth rate.
• The market is driven by the availability of generic formulations, growing healthcare expenditure, and advancements in treatment options.
• Hospital pharmacies remain the dominant distribution channel.
• The market is highly competitive with several major pharmaceutical companies involved.

FAQs

What is the current global market size of levothyroxine?

The global levothyroxine market size is estimated to be USD 3.95 billion in 2024[1].

What is the expected CAGR of the levothyroxine market from 2024 to 2031?

The levothyroxine market is expected to grow at a CAGR of 3.3% to 3.5% from 2024 to 2031[1][4].

Which region is expected to see the highest growth in the levothyroxine market?

The Asia-Pacific region is expected to see the highest growth, with a CAGR of 5.5% from 2024 to 2031[1].

What are the primary drivers of the levothyroxine market?

The primary drivers include the rising prevalence of thyroid disorders, growing healthcare expenditure, and the availability of generic formulations[2][4].

Which distribution channel holds the largest market share in the levothyroxine market?

Hospital pharmacies hold the largest market share due to the high volume of prescriptions filled in these settings[4].

Sources:

1. Cognitive Market Research - Levothyroxine Market Report 2024 (Global Edition)
2. The Business Research Company - Levothyroxine Sodium Global Market Report 2024
3. Business Research Insights - Levothyroxine Sodium Tablet Market Size | Global Report -2031
4. Transparency Market Research - Levothyroxine Market Size, Share, Analysis to 2034
5. PubMed - The Economic Impact of Levothyroxine Dose Adjustments