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Last Updated: April 25, 2025

THYROLAR-2 Drug Patent Profile


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Which patents cover Thyrolar-2, and when can generic versions of Thyrolar-2 launch?

Thyrolar-2 is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in THYROLAR-2 is liotrix (t4;t3). Additional details are available on the liotrix (t4;t3) profile page.

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Summary for THYROLAR-2
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 95
DailyMed Link:THYROLAR-2 at DailyMed
Drug patent expirations by year for THYROLAR-2

US Patents and Regulatory Information for THYROLAR-2

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Allergan THYROLAR-2 liotrix (t4;t3) TABLET;ORAL 016807-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Thyrolar-2

Introduction to Thyrolar-2

Thyrolar-2, a formulation of liotrix, is a medication used for the treatment of hypothyroidism. It combines both triiodothyronine (T3) and levothyroxine (T4) in a single tablet, making it a convenient option for patients requiring thyroid hormone replacement therapy.

Prevalence of Hypothyroidism

The demand for thyroid hormone replacement therapies like Thyrolar-2 is driven by the increasing prevalence of hypothyroidism. Studies indicate that the prevalence of hypothyroidism in the United States has steadily increased since 2009, with estimates suggesting it affects around 11.7% of the population as of 2019[1].

Market Growth

The market for thyroid hormone replacement therapies is growing, partly due to the rising prevalence of hypothyroidism. The anti-thyroid drugs market, which includes treatments for both hyperthyroidism and hypothyroidism, is expected to grow to $2.67 billion by 2026 at a CAGR of 2.30%[3].

Treatment Preferences and Usage

Thyrolar-2 is one of the treatments available for hypothyroidism, and it is often prescribed as part of a broader treatment regimen. The majority of patients with hypothyroidism receive thyroxine (T4) monotherapy, but combination therapies like Thyrolar-2 are also common, especially in cases where T4 alone is insufficient[1].

Financial Performance of Pharmaceutical Companies

Pharmaceutical companies involved in the production and distribution of thyroid hormone replacement therapies, including those like Thyrolar-2, often report significant revenues from these products. For instance, Roivant Sciences, a company involved in various pharmaceutical ventures, reported substantial financial results, although not specifically for Thyrolar-2. Their cash position and revenue streams indicate a robust financial foundation that could support the development and marketing of such therapies[2].

Research and Development Expenses

Companies like Terns Pharmaceuticals, which focus on developing new treatments, incur significant research and development (R&D) expenses. While Terns Pharmaceuticals' financial reports do not specifically mention Thyrolar-2, their R&D expenses of $63.5 million for the year ended December 31, 2023, highlight the investment required to develop and maintain a portfolio of pharmaceutical products, including those for thyroid disorders[5].

Revenue Streams

The revenue generated from thyroid hormone replacement therapies is substantial. For example, the overall revenue from thyroid-related treatments contributes to the broader pharmaceutical market. Companies like Roivant Sciences report product revenues that include sales from various therapeutic areas, including endocrinology, which would encompass thyroid treatments[2].

Competitive Landscape

The market for thyroid hormone replacement therapies is competitive, with multiple products available, including generic and branded options. Thyrolar-2 competes with other combination therapies and monotherapies, and its market share is influenced by factors such as prescription rates, patient compliance, and healthcare provider preferences[4].

Regulatory and Clinical Aspects

Thyrolar-2 is indicated for replacement or supplemental therapy in patients with hypothyroidism of various etiologies. The medication is regulated by stringent guidelines, and its use must be monitored to avoid adverse reactions, such as those indicative of hyperthyroidism due to therapeutic overdosage[4].

Patient Compliance and Adherence

Patient compliance is crucial for the effectiveness of Thyrolar-2. The medication is typically started at low doses and incremented based on the patient's cardiovascular status. Maintenance dosages are adjusted to achieve normal serum T4 and T3 levels, emphasizing the need for careful management and patient adherence[4].

Side Effects and Safety Profile

Thyrolar-2, like other thyroid hormone replacement therapies, has a range of potential side effects, including fatigue, dry skin, palpitations, and weight changes. These side effects are generally manageable but require careful monitoring to ensure the therapy is well-tolerated[4].

Future Outlook

The future outlook for Thyrolar-2 and similar thyroid hormone replacement therapies is positive, driven by the increasing prevalence of hypothyroidism and the ongoing need for effective treatment options. As research continues to advance, there may be new formulations or delivery methods that could further enhance the market for these therapies.

Key Takeaways

  • Increasing Prevalence: Hypothyroidism is becoming more common, driving demand for treatments like Thyrolar-2.
  • Market Growth: The anti-thyroid drugs market is expected to grow to $2.67 billion by 2026.
  • Financial Performance: Pharmaceutical companies report significant revenues and investments in R&D for thyroid-related treatments.
  • Competitive Landscape: The market is competitive, with multiple products available.
  • Regulatory and Clinical Aspects: Thyrolar-2 is regulated strictly, and its use must be carefully managed.
  • Patient Compliance: Patient adherence is crucial for the effectiveness of the medication.

FAQs

Q: What is the primary use of Thyrolar-2?

A: Thyrolar-2 is used as replacement or supplemental therapy in patients with hypothyroidism of any etiology.

Q: How is the prevalence of hypothyroidism affecting the market for Thyrolar-2?

A: The increasing prevalence of hypothyroidism is driving the demand for thyroid hormone replacement therapies like Thyrolar-2.

Q: What are the common side effects of Thyrolar-2?

A: Common side effects include fatigue, dry skin, palpitations, and weight changes.

Q: How does Thyrolar-2 compare to other thyroid hormone replacement therapies?

A: Thyrolar-2 is a combination therapy that includes both T3 and T4, making it a convenient option for patients requiring both hormones.

Q: What is the expected growth of the anti-thyroid drugs market?

A: The anti-thyroid drugs market is expected to grow to $2.67 billion by 2026 at a CAGR of 2.30%.

Cited Sources

  1. Hypothyroidism Prevalence in the United States: A Retrospective Study - Journal of Endocrinology and Society[1]
  2. Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2024 - Roivant Investor Relations[2]
  3. Global Anti-Thyroid Drugs Market Growth Trajectory - EIN Presswire[3]
  4. Thyrolar: Package Insert / Prescribing Information - Drugs.com[4]
  5. Terns Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results - Terns Pharmaceuticals Investor Relations[5]

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