Who Owns Tirosint?
Tirosint (levothyroxine sodium) is owned by IBSA Institut Biochimique SA, a privately held Swiss pharmaceutical company headquartered in Lugano, Switzerland. Tirosint is not a Roche product. The FDA approved Tirosint (levothyroxine sodium capsules) under NDA 021924, with the softgel capsule formulation providing an excipient-free alternative to conventional levothyroxine tablets. IBSA also markets Tirosint-SOL, a liquid levothyroxine solution approved by the FDA, for patients who cannot swallow capsules or require precise dose titration.
Parent Company
Unknown
Founded
2007
Status
Private
Headquarters
Lugano, Switzerland
Who Owns Tirosint?
- Parent Company: Unknown
- Ownership Type: Wholly owned
- Company Type: State-Owned
| Brand | Parent Company | Ownership Type |
|---|---|---|
| Tirosint | Unknown | Wholly owned |
History of Tirosint
- Founded: 2007
- Founders: IBSA Institut Biochimique SA (developer)
Tirosint's development originated from IBSA Institut Biochimique SA's expertise in hormone replacement therapies and its proprietary softgel capsule drug delivery technology. Levothyroxine (synthetic thyroxine, T4) is the standard treatment for hypothyroidism, a condition in which the thyroid gland does not produce sufficient thyroid hormone. Hypothyroidism affects approximately 5 percent of the US population and is one of the most common endocrine disorders, requiring lifelong daily levothyroxine replacement therapy in most patients.
Conventional levothyroxine tablets, including the original branded Synthroid (AbbVie) and numerous generic formulations, contain a variety of inactive ingredients (excipients) including dyes, lactose, gluten, and other fillers that are necessary for tablet manufacturing. While these excipients are generally well-tolerated, some patients experience absorption variability or sensitivities to specific inactive ingredients. Patients with conditions affecting gastrointestinal absorption, such as celiac disease, inflammatory bowel disease, or gastric bypass surgery, may also have difficulty absorbing levothyroxine from conventional tablets.
IBSA developed Tirosint as a softgel capsule formulation of levothyroxine that dissolves levothyroxine sodium in a glycerin and gelatin-based capsule, without the excipients found in conventional tablets. The softgel formulation is designed to provide more consistent and complete absorption of levothyroxine, particularly in patients with gastrointestinal conditions or sensitivities to tablet excipients. The absence of dyes, gluten, lactose, alcohol, and sugar also makes Tirosint suitable for patients with dietary restrictions or allergies to these substances.
The FDA approved Tirosint (levothyroxine sodium capsules) under NDA 021924. The package insert for Tirosint lists IBSA Institut Biochimique SA in Lugano, Switzerland as the manufacturer. Tirosint is available in multiple strengths (13 mcg, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, and 200 mcg) to accommodate the wide range of levothyroxine doses required by patients with varying degrees of hypothyroidism.
IBSA subsequently developed Tirosint-SOL, a liquid levothyroxine solution in unit-dose ampules, which received FDA approval for the US market. Tirosint-SOL provides an alternative for patients who cannot swallow capsules, including pediatric patients, elderly patients, and patients with dysphagia. The liquid formulation also allows for very precise dose titration, which can be important in patients who require fine adjustments to their levothyroxine dose.
Levothyroxine is one of the most widely prescribed medications in the United States, with tens of millions of prescriptions dispensed annually. The levothyroxine market is dominated by generic formulations and the branded Synthroid (AbbVie), which together account for the vast majority of prescriptions. Tirosint occupies a specialty niche within the levothyroxine market, targeting patients who have experienced absorption issues or sensitivities with conventional levothyroxine tablets.
Clinical studies have evaluated the bioavailability and absorption of Tirosint compared to conventional levothyroxine tablets. Research published in medical journals has demonstrated that Tirosint softgel capsules may provide more consistent levothyroxine absorption than conventional tablets in patients with conditions affecting gastrointestinal absorption, supporting the clinical rationale for the excipient-free softgel formulation.
Where Is Tirosint Made / Based?
- Headquarters: Lugano, Switzerland
- Manufacturing / Operations: Switzerland, Italy
Tirosint Ownership: Pros & Cons
Advantages
- +Tirosint's excipient-free softgel capsule formulation, containing no dyes, gluten, lactose, alcohol, or sugar, addresses a genuine clinical need for patients with sensitivities to the inactive ingredients in conventional levothyroxine tablets, providing a differentiated product for a specific patient population
- +The softgel capsule delivery system, which dissolves levothyroxine in a glycerin and gelatin matrix, may provide more consistent levothyroxine absorption than conventional tablets in patients with gastrointestinal conditions affecting absorption, such as celiac disease, inflammatory bowel disease, or post-bariatric surgery
- +The availability of Tirosint-SOL (liquid levothyroxine solution in unit-dose ampules) extends IBSA's levothyroxine franchise to patients who cannot swallow capsules, including pediatric patients and patients with dysphagia, broadening the addressable patient population
- +IBSA's focus as a specialty pharmaceutical company on hormone therapies and innovative drug delivery technologies provides deep expertise in levothyroxine formulation and endocrinology that supports continued product development and physician education
- +Tirosint's multiple available strengths (13 mcg through 200 mcg) accommodate the full range of levothyroxine doses required by hypothyroid patients, supporting use across the entire patient population
Considerations
- -Tirosint's significantly higher cost compared to generic levothyroxine tablets creates a substantial barrier to adoption, as most patients with hypothyroidism can be effectively managed with inexpensive generic levothyroxine, limiting Tirosint's addressable market to patients with specific clinical needs
- -The levothyroxine market is dominated by generic formulations and the well-established branded Synthroid (AbbVie), which together account for the vast majority of prescriptions, making it challenging for Tirosint to achieve broad market penetration
- -IBSA is a privately held company with limited public financial disclosure, making it difficult to assess the commercial performance of Tirosint or the company's financial resources for marketing and product development
- -Insurance coverage for Tirosint may be limited compared to generic levothyroxine, as payers may require prior authorization or step therapy (requiring failure of generic levothyroxine first) before approving Tirosint, creating access barriers for some patients
- -The clinical evidence supporting Tirosint's superiority over conventional levothyroxine tablets in the general hypothyroid population is limited, with most studies focusing on specific patient subgroups with absorption issues, which may limit physician willingness to prescribe Tirosint for routine hypothyroidism management
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