TIROSINT Drug Patent Profile

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

Tirosint is a drug marketed by Ibsa and is included in two NDAs. There are five patents protecting this drug and five Paragraph IV challenges.

This drug has nineteen patent family members in nine countries.

The generic ingredient in TIROSINT 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

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

Summary for TIROSINT

International Patents:	19
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	7
Patent Applications:	2,689
Drug Prices:	Drug price information for TIROSINT
Drug Sales Revenues:	Drug sales revenues for TIROSINT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIROSINT
What excipients (inactive ingredients) are in TIROSINT?	TIROSINT excipients list
DailyMed Link:	TIROSINT at DailyMed

See drug prices for TIROSINT

See drug sales revenues for TIROSINT

Recent Clinical Trials for TIROSINT

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 clinical trials

Pharmacology for TIROSINT

Drug Class

l-Thyroxine

Paragraph IV (Patent) Challenges for TIROSINT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIROSINT	Capsules	levothyroxine sodium	137 mcg and 175 mcg	021924	1	2022-11-04
TIROSINT	Capsules	levothyroxine sodium	200 mcg	021924	1	2021-12-30
TIROSINT	Capsules	levothyroxine sodium	112 mcg	021924	1	2020-12-18
TIROSINT	Capsules	levothyroxine sodium	88 mcg, 100 mcg and 125 mcg	021924	1	2019-08-01
TIROSINT	Capsules	levothyroxine sodium	75 mcg and 150 mcg	021924	1	2017-12-29

US Patents and Regulatory Information for TIROSINT

TIROSINT is protected by two 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	206977-009	Dec 15, 2016		RX	Yes	No	11,241,382
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-002	Dec 15, 2016		RX	Yes	No	11,241,382
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-012	Dec 15, 2016		RX	Yes	Yes	11,096,913		Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-006	Dec 15, 2016		RX	Yes	No	11,241,382

Expired US Patents for TIROSINT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-012	Apr 25, 2017	7,691,411
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-012	Apr 25, 2017	7,723,390
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-003	Oct 13, 2006	7,723,390
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-010	Oct 2, 2009	7,691,411

International Patents for TIROSINT

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

Country	Patent Number	Title	Estimated Expiration
Canada	2392545	PREPARATIONS PHARMACEUTIQUES POUR HORMONES THYROIDIENNES (PHARMACEUTICAL FORMULATIONS FOR THYROID HORMONES)
Germany	60329968
Austria	312621
Japan	5105685

Supplementary Protection Certificates for TIROSINT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1291021	132012902104794	Italy		PRODUCT NAME: LEVOTIROXINA SODICA(ALIASINT); AUTHORISATION NUMBER(S) AND DATE(S): RVG 106848; 106850-106860, 20110407;DA 041528011/M A 041528365/M, 20120808

TIROSINT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tirosint

Introduction to Tirosint

Tirosint, a brand name for levothyroxine sodium, is a synthetic form of the thyroid hormone thyroxine. It is used to treat hypothyroidism and for TSH suppression in the management of certain thyroid cancers. The drug has been available in various forms, including tablets and, more recently, a liquid solution.

FDA Approval and Market Entry

In 2017, the FDA approved Tirosint-SOL, a liquid form of levothyroxine, for the American market. This approval marked a significant milestone for IBSA, the Italian-Swiss company that developed the liquid formulation. The FDA approval opened up a substantial market opportunity, with an estimated 18 million patients in the U.S. and a market valued at $2 billion to $105 million prescriptions annually[1].

Clinical Significance and Advantages

The liquid form of Tirosint has several clinical advantages over traditional tablet forms. Clinical studies have shown that Tirosint-SOL can overcome some of the limitations associated with levothyroxine tablets, such as interference from gastritis, coeliac disease, lactose intolerance, and certain foods and medications. For instance, patients using the liquid form do not need to wait an hour before eating breakfast, and the absorption is less affected by antacids or proton pump inhibitors[1].

Market Size and Growth

The global levothyroxine sodium market, which includes both tablet and liquid forms, is substantial and growing. As of 2022, the global levothyroxine sodium tablet market was valued at USD 3,713.7 million and is projected to reach USD 4,367.6 million by 2028, with a Compound Annual Growth Rate (CAGR) of 2.7%[3].

For the broader levothyroxine sodium market, including both oral and injection forms, the market size was valued at USD 3.9 billion in 2022 and is expected to grow further. The market is driven by the rising prevalence of thyroid disorders and growing awareness about the links between thyroid health and women's fertility[4].

Segmentation and Applications

The levothyroxine sodium market is segmented by type (oral and injection) and by application (hospitals, pharmacies, and others). The oral segment, which includes Tirosint, dominates the market due to its widespread use in treating hypothyroidism and other thyroid-related conditions[4].

Financial Trajectory and Cost Savings

For patients, the financial trajectory of using Tirosint can be managed through various cost-saving programs. The Tirosint Copay Savings Card allows patients with commercial insurance to pay as little as $25 for a month’s supply or $60 for a 90-day supply. The Tirosint Direct Program offers additional savings through mail-order pharmacies, providing the lowest cash price available and convenient home delivery[2].

Cost Savings Programs

• Tirosint Copay Savings Card: Offers significant savings for patients with commercial insurance, making the medication more affordable.
• Tirosint Direct Program: Provides the lowest cash price available and the convenience of home delivery, saving both money and time[2].

Market Opportunities and Challenges

Opportunities

• Growing Market: The increasing prevalence of thyroid disorders and the expanding awareness of thyroid health create a growing market for Tirosint.
• Innovative Formulation: The liquid form of Tirosint offers advantages over traditional tablets, making it an attractive option for patients with specific needs[1].

Challenges

• Competition: The levothyroxine market is highly competitive, with multiple brands and generic options available.
• Regulatory Environment: Changes in regulatory policies and patent expirations can impact the market dynamics and profitability of branded drugs like Tirosint[5].

Expert Insights

According to Arturo Licenziati, President of IBSA SA, the FDA approval of Tirosint-SOL opens up very interesting opportunities for the company, particularly in the U.S. market. He highlights the success of clinical trials in Italy, which have been published in numerous international scientific journals, demonstrating the efficacy and advantages of the liquid formulation[1].

Leonard Wartofsky, MD, MACP, Past President of the American Thyroid Association, emphasizes the widespread nature of hypothyroidism in the U.S. and the importance of precise dosing and absorption of levothyroxine. He notes that the synthetic form of levothyroxine, available since 1950, has undergone a significant innovation with the development of the liquid form[1].

Key Takeaways

• Market Growth: The global levothyroxine sodium market is expected to grow, driven by increasing prevalence of thyroid disorders.
• Innovative Formulation: Tirosint-SOL offers clinical advantages over traditional tablet forms.
• Cost Savings: Various programs are available to make Tirosint more affordable for patients.
• Market Opportunities: Growing awareness and innovative formulations present opportunities for market expansion.
• Challenges: Competition and regulatory changes are key challenges in the market.

FAQs

What is Tirosint used for?

Tirosint is used to treat hypothyroidism and for TSH suppression in the management of certain thyroid cancers.

How does the liquid form of Tirosint differ from traditional tablets?

The liquid form of Tirosint overcomes some limitations of tablets, such as interference from certain foods and medications, and does not require waiting an hour before eating breakfast.

What cost-saving programs are available for Tirosint?

Patients can use the Tirosint Copay Savings Card or the Tirosint Direct Program to save on their prescriptions.

What is the projected market size for the levothyroxine sodium market by 2028?

The global levothyroxine sodium tablet market is expected to reach USD 4,367.6 million by 2028.

Are patients on government healthcare programs eligible for the Tirosint Copay Savings Card?

No, patients participating in government healthcare programs (Medicare, Medicaid, VA/DOD) are not eligible to use the Tirosint copay savings program.

Sources

1. The FDA Has Approved Tirosint-SOL, Levothyroxine In Liquid Solution For The American Market, IBSA Patent. Biospace.
2. Ways to save - Tirosint® Capsules. Tirosint.
3. Levothyroxine Sodium Tablet Market Size | Global Report -2031. Business Research Insights.
4. Levothyroxine Sodium Market Size, Share Trends Report 2032. Market Research Future.
5. National Medicaid Fee-For-Service Drug Utilization Review. Medicaid.gov.