Bimatoprost

Glaucoma is the leading irreversible blinding eye disease globally, among which open-angle glaucoma has insidious early symptoms, and about 70% of patients have already developed irreversible optic nerve damage at the time of clinical diagnosis. As a prostaglandin analog hypotensive drug, bimatoprost exerts its effect by increasing aqueous humor outflow through the uveoscleral pathway. It is currently the first-line drug with the highest single-drug intraocular pressure lowering amplitude. It is not only suitable for long-term intraocular pressure control in patients with primary open-angle glaucoma and ocular hypertension, but also can be used as an alternative treatment for patients with poor response to other hypotensive drugs, and some dosage forms can also assist in the treatment of hypotrichosis of the eyelashes.

Data show that the global market size of anti-glaucoma drugs has exceeded 8 billion US dollars in 2023, among which prostaglandin analogs account for more than 45%, making them the market segment with the highest share. The compound annual growth rate of the domestic glaucoma medication market size in the past 5 years has reached 8.2%, and it was approximately 3.8 billion yuan in 2023. As the preferred drug recommended by clinical guidelines, the market penetration rate of bimatoprost is continuously increasing. At present, the bimatoprost preparations sold in China are mainly products of the original research manufacturer and leading generic pharmaceutical enterprises. After winning the bid in the centralized procurement in 2021, the terminal price has dropped by more than 80%, which further promotes the accessibility of medication at the primary level.

The original research enterprise of bimatoprost is Alcon, and the original research trade name is Lumigan. The expiration date of its core compound patent in the United States is 2024, and the compound patent in China expired in 2019. The mainstream dosage form of the original research product is eye drops, with the common specification of 0.03% (3ml:0.9mg). It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the NMPA, and is also included in the FDA Reference Preparations Catalogue. At present, the bimatoprost active pharmaceutical ingredients (APIs) of more than 10 domestic enterprises have obtained Class A status through CDE registration, and domestic preparations have also been approved for marketing by multiple manufacturers, with the number of varieties that have passed the consistency evaluation increasing continuously. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of bimatoprost impurity reference standards, which can fully cover the research needs of API production process impurities and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support pharmaceutical enterprises in API registration and declaration, quality research and daily quality control work.