Levothyroxine

Hypothyroidism is a chronic endocrine disease with a high incidence worldwide, and patients require long-term hormone replacement therapy to maintain normal physiological metabolism. Levothyroxine, as a synthetic tetraiodothyronine, has exactly the same structure as the thyroxine naturally secreted by the human thyroid gland. After entering the body, it can be converted into triiodothyronine with higher activity, and regulates gene expression by binding to thyroid hormone receptors in the nucleus, thereby realizing physiological effects such as basal metabolic rate regulation and growth and development maintenance. In addition to the long-term replacement therapy for primary and secondary hypothyroidism, this drug can also be used for non-toxic goiter, postoperative suppressive therapy for thyroid cancer, and adjuvant suppression test for hyperthyroidism. It is currently the first-line drug of choice for the treatment of hypothyroidism, and the applicable population covers patients of all age groups including children, adults and the elderly.

The global market size of levothyroxine preparations is stably above 3 billion US dollars, with an annual compound growth rate maintained in the range of 3%-5%. In recent years, with the improvement of the penetration rate of hypothyroidism screening in the Chinese market, the growth rate is higher than the global average level. In 2023, the terminal sales of domestic public medical institutions exceeded 4 billion yuan. The competitive landscape is characterized by the dominance of the original research drug and the gradual replacement of generic drugs. The original research product accounts for nearly 70% of the domestic market share. More than 10 domestic pharmaceutical companies have been approved for generic drug preparations, among which 4 companies' products have passed the consistency evaluation. After this variety was included in the local centralized procurement in 2022, the market share of generic drugs has increased significantly.

The original research enterprise of levothyroxine is Merck KGaA, Germany, and the original research trade name is Euthyrox. Its core compound patent expired worldwide in 1997. At present, the original research dosage form approved in China is tablet, with specifications of 50μg and 100μg. It has been included in the *Catalog of Reference Preparations of Chemical Drugs* issued by the National Medical Products Administration, and is also a reference preparation recognized by the FDA. Up to now, more than 20 domestic enterprises' levothyroxine active pharmaceutical ingredients have obtained A status through CDE registration, which can be used for associated preparation declaration. In addition, more than 30 domestic levothyroxine sodium tablet preparations have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for levothyroxine API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for the whole process of R&D, production and quality control of API and preparation enterprises.