TIROSINT-SOL Drug Patent Profile

Which patents cover Tirosint-sol, and when can generic versions of Tirosint-sol launch?

Tirosint-sol is a drug marketed by Ibsa and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in thirteen countries.

The generic ingredient in TIROSINT-SOL 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 Tirosint-sol

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

Summary for TIROSINT-SOL

International Patents:	22
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	7
Patent Applications:	3,016
Drug Prices:	Drug price information for TIROSINT-SOL
DailyMed Link:	TIROSINT-SOL at DailyMed

See drug prices for TIROSINT-SOL

Recent Clinical Trials for TIROSINT-SOL

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

Sponsor	Phase
Cromsource	Phase 4
University of California, Los Angeles	Phase 4
Children's Mercy Hospital Kansas City	Phase 4

See all TIROSINT-SOL clinical trials

Pharmacology for TIROSINT-SOL

Drug Class

l-Thyroxine

Paragraph IV (Patent) Challenges for TIROSINT-SOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIROSINT-SOL	Oral Solution	levothyroxine sodium	13 mcg/mL 25 mcg/mL 50 mcg/mL 75 mcg/mL 88 mcg/mL 100 mcg/mL 112 mcg/mL 125 mcg/mL 137 mcg/mL 150 mcg/mL 175 mcg/mL 200 mcg/mL	206977	1	2022-09-30

US Patents and Regulatory Information for TIROSINT-SOL

TIROSINT-SOL is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-008	Dec 15, 2016		RX	Yes	No
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-005	Dec 15, 2016		RX	Yes	No			Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-010	Dec 15, 2016		RX	Yes	No
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-012	Dec 15, 2016		RX	Yes	Yes			Y

International Patents for TIROSINT-SOL

See the table below for patents covering TIROSINT-SOL around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	3528847
Russian Federation	2765547	ВЫСОКОСТАБИЛЬНЫЕ УПАКОВАННЫЕ РАСТВОРЫ ТИРЕОИДНОГО ГОРМОНА Т4 (HIGHLY STABLE PACKAGED SOLUTIONS OF THE THYROID HORMONE T4)
Denmark	3528847
Portugal	3930703

TIROSINT-SOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tirosint-SOL (Levothyroxine Sodium Oral Solution)

Introduction to Tirosint-SOL

Tirosint-SOL, a liquid formulation of levothyroxine sodium, has been a significant innovation in the treatment of hypothyroidism and TSH suppression. Approved by the FDA in 2017, this medication has been developed by IBSA, an Italian-Swiss company, and has been available in the Italian market since 2012[1].

Market Opportunity

The approval of Tirosint-SOL for the US market has opened up a substantial market opportunity. Hypothyroidism is a widespread condition, affecting at least 6% of the US population, with the most frequent cause being chronic autoimmune thyroiditis. This translates to a large patient base, estimated at 18 million, with a market valued at $2 billion and involving 105 million prescriptions annually[1].

Clinical Advantages

Tirosint-SOL offers several clinical advantages over traditional levothyroxine tablets. It can be administered 15 minutes before breakfast, unlike tablets which often require a wait of at least an hour before eating. Additionally, it does not interact with proton pump inhibitors (PPIs), antacids, or other medications that can interfere with the absorption of levothyroxine tablets[2].

Overcoming Limitations of Traditional Levothyroxine

Clinical trials have demonstrated that Tirosint-SOL can overcome some of the limitations associated with levothyroxine tablets. For instance, it does not require patients to wait before eating, and its absorption is not affected by gastritis, coeliac disease, lactose intolerance, or the intake of certain foods and medications[1].

Dosage Flexibility

Tirosint-SOL offers a wide range of dosing strengths, including unique options such as 13, 37.5, 44, and 62.5 micrograms, providing clinicians with greater precision and flexibility in treating patients. This extensive range of 15 dosing strengths is unparalleled in the US market for levothyroxine therapies[4].

Patient and Clinician Benefits

Convenience and Precision

The liquid formulation of Tirosint-SOL is particularly beneficial for patients who have difficulty swallowing tablets or are fed through tubes. It also eliminates the need for splitting tablets, which can lead to dosing errors, especially in pediatric patients or those requiring precise dosing[4].

Patient Satisfaction

Research has shown that frequent dose titration of thyroid hormone treatment can lead to lower patient satisfaction. The extensive dosing options of Tirosint-SOL help reduce the need for frequent dose changes, potentially increasing patient satisfaction with their hypothyroidism therapy[4].

Financial Aspects

Pricing and Savings Programs

IBSA offers several financial assistance programs to make Tirosint-SOL more accessible. The Tirosint Direct program allows patients to purchase the medication at a fixed price of $65 for a 30-day supply or $170 for a 90-day supply, regardless of insurance coverage. Additionally, a Copay Savings Card is available to reduce out-of-pocket costs for patients with commercial insurance[5].

Market Impact

The unique formulation and clinical advantages of Tirosint-SOL have positioned it as a preferred option for many clinicians and patients. The lack of interaction with PPIs and the ability to administer it shortly before breakfast are significant differentiators in the market. These factors contribute to its growing market share and financial performance.

Regulatory Updates

Recent Label Changes

In 2023, the FDA approved two new label changes for Tirosint-SOL. These changes highlight the medication's lack of interaction with proton pump inhibitors and its ability to be administered 15 minutes before breakfast, further solidifying its position in the market[2].

Competitive Landscape

Tirosint-SOL competes in a market dominated by traditional levothyroxine tablets and capsules. However, its unique formulation and extensive dosing options set it apart from other treatments. The absence of interactions with common medications and its convenience in administration make it a preferred choice for many patients and clinicians[3].

Future Outlook

Given its clinical advantages, extensive dosing options, and financial assistance programs, Tirosint-SOL is poised for continued growth in the US market. The increasing awareness of its benefits among healthcare providers and patients is likely to drive its adoption and market share.

Expanding Patient Base

The medication's suitability for a wide range of patients, including those with difficulty swallowing or requiring precise dosing, ensures a broad and expanding patient base. This, combined with the growing prevalence of hypothyroidism, suggests a positive financial trajectory for Tirosint-SOL.

Key Takeaways

• Market Opportunity: Tirosint-SOL addresses a large and growing market for hypothyroidism treatment, with an estimated 18 million patients in the US.
• Clinical Advantages: It offers superior convenience and precision over traditional levothyroxine tablets, with no interactions with PPIs or other medications.
• Dosage Flexibility: Provides 15 dosing strengths, the widest range available in the US market.
• Financial Assistance: Available through programs like Tirosint Direct and Copay Savings Card.
• Regulatory Updates: Recent FDA label changes further differentiate Tirosint-SOL in the market.
• Competitive Landscape: Unique formulation sets it apart from traditional treatments.

FAQs

Q: What is Tirosint-SOL used for?

Tirosint-SOL is used for the treatment of hypothyroidism and TSH suppression in the management of some thyroid cancers.

Q: What are the unique dosing strengths of Tirosint-SOL?

Tirosint-SOL is available in 15 dosing strengths, including unique options such as 13, 37.5, 44, and 62.5 micrograms.

Q: How does Tirosint-SOL differ from traditional levothyroxine tablets?

Tirosint-SOL can be administered 15 minutes before breakfast and does not interact with proton pump inhibitors or other medications that can affect the absorption of levothyroxine tablets.

Q: What financial assistance programs are available for Tirosint-SOL?

IBSA offers the Tirosint Direct program and a Copay Savings Card to reduce out-of-pocket costs for patients.

Q: Is Tirosint-SOL suitable for all patients with hypothyroidism?

Yes, Tirosint-SOL is indicated for patients of all ages, including those who have difficulty swallowing tablets or are fed through tubes.

Sources:

1. The FDA Has Approved Tirosint-SOL, Levothyroxine In Liquid Solution for the American Market - Biospace
2. Food And Drug Administration Grants Two New Label Changes To Tirosint-SOL (Levothyroxine Sodium) Oral Solution - Business Wire
3. Clinical Review Tirosint-SOL - FDA
4. Dosage Flexibility of Liquid Hypothyroidism Treatment Introduced for Patients and Clinicians - Endocrine News
5. Tirosint® Direct Program - TirosintSOL.com