THYQUIDITY Drug Patent Profile

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

Thyquidity is a drug marketed by Azurity and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eleven patent family members in eleven countries.

The generic ingredient in THYQUIDITY 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 Thyquidity

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

Summary for THYQUIDITY

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Patent Applications:	454
Drug Prices:	Drug price information for THYQUIDITY
What excipients (inactive ingredients) are in THYQUIDITY?	THYQUIDITY excipients list
DailyMed Link:	THYQUIDITY at DailyMed

See drug prices for THYQUIDITY

Pharmacology for THYQUIDITY

Drug Class

l-Thyroxine

Paragraph IV (Patent) Challenges for THYQUIDITY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
THYQUIDITY	Oral Solution	levothyroxine sodium	100 mcg/5 mL	214047	1	2022-12-28

US Patents and Regulatory Information for THYQUIDITY

THYQUIDITY is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	THYQUIDITY	levothyroxine sodium	SOLUTION;ORAL	214047-001	Nov 30, 2020		RX	Yes	Yes			Y

International Patents for THYQUIDITY

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012120338
Cyprus	1117151
Croatia	P20151421
Poland	2683361
Slovenia	2683361
European Patent Office	2683361	MÉTHODE DE MANUFACTURE D'UNE SOLUTION DE LÉVOTHYROXINE (METHOD FOR THE PREPARATON OF A LEVOTHYROXINE SOLUTION)
Spain	2559818

THYQUIDITY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for THYQUIDITY (Levothyroxine Sodium Oral Solution)

Introduction to THYQUIDITY

THYQUIDITY, developed by Vertice Pharma, is a liquid oral solution of levothyroxine sodium, indicated for replacement therapy in primary, secondary, and tertiary hypothyroidism, as well as for the management of thyrotropin-dependent well-differentiated thyroid cancer. This product marks a significant advancement in the treatment of hypothyroidism, especially for patients who have difficulty swallowing tablets[1][2][3].

Market Context

The levothyroxine market, within which THYQUIDITY operates, is substantial and growing. As of 2023, the global levothyroxine market was valued at $3.8 billion and is projected to grow at a CAGR of 3.3% from 2024 to 2034, reaching $5.4 billion by the end of the forecast period. North America dominates this market, largely due to the high prevalence of thyroid disorders in the U.S. population[4].

Key Market Drivers

Growing Prevalence of Thyroid Disorders

The increasing awareness and diagnosis of thyroid disorders are significant drivers for the levothyroxine market. Approximately 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[4].

Dosing Flexibility and Patient Compliance

THYQUIDITY offers broad dosing flexibility and consistent daily dosing, which is particularly beneficial for patients, especially children, who cannot swallow tablets. This flexibility enhances patient compliance and satisfaction, contributing to the product's market appeal[1][3].

Co-Promotion Agreement

The co-promotion agreement between Vertice Pharma and MannKind Corporation is another key factor. MannKind’s specialty sales force promotes THYQUIDITY to adult and pediatric endocrinologists and other U.S. healthcare providers, expanding the product's reach and potential market share[1][2].

Financial Trajectory

Launch and Initial Impact

The launch of THYQUIDITY in 2021 marked Vertice Pharma's first branded pharmaceutical prescription product. This launch is part of Vertice's strategy to deliver high-quality and affordable pharmaceutical products, reflecting their commitment to the market[1].

Revenue Potential

Given the growing demand for levothyroxine products and the unique benefits of THYQUIDITY, such as its liquid dosage form and dosing flexibility, the product is poised to capture a significant share of the market. The financial performance of THYQUIDITY is expected to be robust, especially as it leverages the extensive sales network of MannKind[1][2].

Competitive Landscape

The levothyroxine market is competitive, with key players including AbbVie, Mylan N.V., Merck & Co., Inc., Pfizer Inc., and others. However, THYQUIDITY's unique formulation and the co-promotion agreement with MannKind position it favorably in the market. The product's bioequivalence to Synthroid, a well-established levothyroxine product, further supports its market potential[3][4].

Risk and Risk Management

Therapeutic Index and Dosage Titration

THYQUIDITY has a narrow therapeutic index, requiring careful dosage titration to avoid over- or under-treatment. This necessitates close monitoring by healthcare providers, which can impact patient adherence and overall market performance[2].

Interactions and Side Effects

The product may interact with other medications, such as antidiabetic agents, and can affect glycemic control. Additionally, there is a risk of increased bone resorption and decreased bone mineral density, particularly in postmenopausal women. These factors must be managed through careful patient monitoring and dosage adjustment[2].

Market Attractiveness

Distribution Channels

THYQUIDITY is expected to be distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies accounted for the largest share in 2023, indicating a strong institutional demand for the product[4].

Geographic Performance

North America is the dominant region for levothyroxine products, and THYQUIDITY is expected to perform well in this market. Europe and the Asia Pacific region also present significant opportunities due to the higher prevalence of thyroid disorders among the elderly and growing healthcare infrastructure[4].

Key Takeaways

• Growing Market: The levothyroxine market is growing, driven by increasing prevalence of thyroid disorders.
• Unique Formulation: THYQUIDITY's liquid oral solution offers dosing flexibility, enhancing patient compliance.
• Co-Promotion: The agreement with MannKind expands the product's reach to healthcare providers.
• Financial Potential: Strong revenue potential due to market demand and competitive positioning.
• Risk Management: Careful dosage titration and monitoring are necessary to manage risks associated with THYQUIDITY.

FAQs

Q: What is THYQUIDITY indicated for?

THYQUIDITY is indicated as a replacement therapy in primary, secondary, and tertiary hypothyroidism, as well as for the management of thyrotropin-dependent well-differentiated thyroid cancer[1][2].

Q: What makes THYQUIDITY unique?

THYQUIDITY is a liquid oral solution of levothyroxine sodium, offering broad dosing flexibility and consistent daily dosing, which is particularly beneficial for patients who cannot swallow tablets[1][3].

Q: Who is promoting THYQUIDITY?

THYQUIDITY is being co-promoted by Vertice Pharma and MannKind Corporation through MannKind’s specialty sales force[1][2].

Q: What are the potential risks associated with THYQUIDITY?

THYQUIDITY has a narrow therapeutic index, requiring careful dosage titration. It may also interact with other medications and affect glycemic control, and there is a risk of increased bone resorption and decreased bone mineral density[2].

Q: How is THYQUIDITY distributed?

THYQUIDITY is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies[4].

References

1. Vertice Pharma Launches THYQUIDITY™ (levothyroxine sodium) Oral Solution. Biospace.
2. MannKind and Vertice to Co-Promote Thyquidity™ (levothyroxine sodium) Oral Solution. MannKind Corporation.
3. FDA Approval Document for THYQUIDITY. FDA.
4. Levothyroxine Market Size, Share, Analysis to 2034. Transparency Market Research.