LEVO-T Drug Patent Profile

When do Levo-t patents expire, and what generic alternatives are available?

Levo-t is a drug marketed by Cediprof Inc and is included in one NDA.

The generic ingredient in LEVO-T 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 Levo-t

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

Summary for LEVO-T

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	166
Patent Applications:	3,021
Drug Prices:	Drug price information for LEVO-T
What excipients (inactive ingredients) are in LEVO-T?	LEVO-T excipients list
DailyMed Link:	LEVO-T at DailyMed

See drug prices for LEVO-T

Pharmacology for LEVO-T

Drug Class

l-Thyroxine

US Patents and Regulatory Information for LEVO-T

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-001	Mar 1, 2002	AB1,AB2,AB3	RX	No	No
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-007	Mar 1, 2002	AB1,AB2,AB3	RX	No	No
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-004	Mar 1, 2002	AB1,AB2,AB3	RX	No	No

Expired US Patents for LEVO-T

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-010	Mar 1, 2002
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-005	Mar 1, 2002
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-009	Mar 1, 2002

International Patents for LEVO-T

See the table below for patents covering LEVO-T around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2404369
European Patent Office	1267999
Australia	2001252953

LEVO-T Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LEVO-T (Levothyroxine)

Market Overview

Levothyroxine, commonly known by brand names such as LEVO-T, is a synthetic form of the thyroid hormone thyroxine (T4), used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. Here’s a detailed look at the market dynamics and financial trajectory of LEVO-T.

Growing Prevalence of Thyroid Disorders

The increasing prevalence of thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroid cancer, is a significant driver of the levothyroxine market. This trend is expected to continue, fueled by genetic predisposition, environmental influences, and lifestyle changes[1][4].

Market Size and Growth

The global levothyroxine market, which includes LEVO-T, was valued at approximately $3.8 billion in 2023. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.3% from 2024 to 2034, reaching $5.4 billion by the end of the forecast period[4].

Regional Dominance

North America, particularly the United States, dominates the levothyroxine market due to high awareness among the population about thyroid disorders and a sophisticated healthcare system. This region is expected to maintain its dominance throughout the forecast period[4].

Sales Channels

The distribution of LEVO-T and other levothyroxine products is primarily through hospitals, specialty clinics, retail pharmacies, and online pharmacies. Hospital pharmacies currently hold the largest share, but retail pharmacies are expected to lead the sales channel category by 2034, providing convenient access and medication management services to patients[1][4].

Pricing and Affordability

The cost of LEVO-T varies based on dosage and quantity. For example, a supply of 90 tablets of LEVO-T (25 mcg) can cost around $44, with generic versions available at lower prices starting from $21.30 for 90 tablets. This pricing structure makes the medication relatively affordable for a wide range of patients[2].

Key Players and Competitive Landscape

The market for levothyroxine is competitive, with major players including AbbVie Inc., Mylan N.V., Merck & Co., Inc., Pfizer Inc., Lannett Company Inc, Novartis AG, Fresenius Kabi, and Abbott Laboratories. These companies are focusing on strategic collaborations, mergers, and new product developments to maintain their market positions[4].

Financial Trajectory

Revenue Growth

The injectable thyroid drug market, which includes levothyroxine products like LEVO-T, is expected to grow significantly. From a base value of $414.4 million in 2023, the market is projected to reach $439.65 million in 2024 and $765.4 million by 2034, with a CAGR of 5.7%[1].

Regional Revenue

In the United States, the market for injectable thyroid drugs, including LEVO-T, is expected to exhibit a CAGR of 4.2% during the forecast period. Other regions, such as Canada and France, are also expected to show significant growth, with CAGRs of 5.6% and 5.3%, respectively[1].

Distribution Channel Revenue

Hospitals currently account for 33.5% of the industry share and are expected to grow at a CAGR of 5.1%. However, retail pharmacies are anticipated to lead the sales channel category by 2034, driven by their ability to provide comprehensive medication management services[1].

Innovations and Developments

Companies in the levothyroxine market are focusing on innovation through new product launches and developments. This includes the introduction of new formulations and delivery methods, such as injectable forms, which are gaining traction due to their convenience and efficacy[1].

Regulatory Framework

The regulatory environment, particularly in the United States, plays a crucial role in ensuring the safety, efficacy, and quality of thyroid medications. The FDA's stringent standards instill confidence in both domestic and international markets, supporting the growth of the levothyroxine market[1].

Patient Education and Adherence

Pharmacists play a vital role in educating patients on the proper administration of LEVO-T and other levothyroxine products. This includes dosage instructions, side effects, and medication adherence, which are critical for optimizing treatment outcomes[1].

Key Takeaways

• The levothyroxine market, including LEVO-T, is driven by the rising prevalence of thyroid disorders.
• North America, particularly the United States, dominates the market due to high awareness and a sophisticated healthcare system.
• Retail pharmacies are expected to lead the sales channel category by 2034.
• The market is projected to grow at a CAGR of 3.3% from 2024 to 2034.
• Companies are focusing on strategic collaborations and new product developments to stay competitive.

FAQs

Q: What is the current market size of the levothyroxine market?

The global levothyroxine market was valued at approximately $3.8 billion in 2023[4].

Q: What is the projected growth rate of the levothyroxine market?

The levothyroxine market is expected to grow at a CAGR of 3.3% from 2024 to 2034[4].

Q: Which region dominates the levothyroxine market?

North America, particularly the United States, dominates the levothyroxine market[4].

Q: What are the primary sales channels for LEVO-T and other levothyroxine products?

The primary sales channels include hospitals, specialty clinics, retail pharmacies, and online pharmacies[1][4].

Q: How much does LEVO-T typically cost?

The cost of LEVO-T can range from $21.30 to $62.25 for a supply of 90 tablets, depending on the dosage and pharmacy[2].

Sources

1. Future Market Insights: Injectable Thyroid Drug Market Share, Trend & Forecast 2034
2. Drugs.com: Levo-T Prices, Coupons, Copay Cards & Patient Assistance
3. Ultragenyx Pharmaceutical Inc.: Finance and capital markets. Corporate strategy
4. Transparency Market Research: Levothyroxine Market Size, Share, Analysis to 2034