Rivaroxaban API and Tablet Process Transfer
Basic Information
Name: Rivaroxaban
Aliases: BAY-59-7939; JNJ-39039039
Brand Name: Xarelto, Bayerto
Dosage Form: Tablet (Xarelto Fine Granule marketed in Japan)
Specification: 2.5 mg, 10 mg, 15 mg, 20 mg
Indication: For the prevention or reduction of thrombosis, deep vein thrombosis (DVT), and pulmonary embolism (PE) following hip or knee replacement surgery.
Dosage and Administration: The recommended dose is 10 mg of Rivaroxaban orally once daily. Rivaroxaban 10 mg can be taken with or without food. Rivaroxaban 15 mg or 20 mg tablets should be taken with food.
Chemical Structure:
[Structure not provided in text]
Molecular Formula: C19H18ClN3O5S
Molecular Weight: 435.88
Chemical Name: 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}-2-thiophene-carboxamide
CAS Registry Number: 366789-02-8
Market Status:
This product was developed by Bayer, Germany, and is the world’s first highly selective oral anticoagulant that directly inhibits Factor Xa. It was first launched in Canada in September 2008, received EU approval in October 2008, and was marketed in the United States by Johnson & Johnson in July 2011. Currently, Rivaroxaban has been approved in over 100 countries worldwide and successfully marketed by Bayer in more than 75 countries. It was officially launched in China in June 2009 under the brand name Bayerto.
Registration Category: Chemical Drug Category 4
Domestic Status: Imported and marketed in China; generic versions not yet marketed. Six companies, including Nanjing Chia Tai Tianqing and Shenzhen Salubris, are currently conducting bioequivalence clinical trials.
