Celecoxib API Process Transfer
Basic Information
Generic Name: Celecoxib
English Name: Celecoxib
Chemical Name: 4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide
Chemical Formula:
Molecular Formula: C17H14F3N3O2S
Molecular Weight: 381.37
Indications: Symptoms and signs of osteoarthritis and rheumatoid arthritis in acute or chronic phases.
Global Market Launch:
Celecoxib was jointly developed by Pfizer and Astellas. It was first approved by the FDA on December 31, 1998, launched in the EU in 2003, in Japan in 2007, and entered the Chinese market in 2012.
Patent Status: Relevant patents have expired.
Registration Status: Currently, only Pfizer imports Celecoxib in China, with API and capsules (specifications: 0.1g, 0.2g). There are 19 domestic companies applying for registration.
Market Prospects:
Celecoxib, co-developed by Pharmacia and Pfizer, is a new-generation compound with a unique mechanism of action, specifically inhibiting cyclooxygenase-2 (COX-2). It reduces inflammation, pain, and fever by inhibiting COX-2, which prevents the production of inflammatory prostaglandins. It is an effective, low-side-effect, and safe treatment for osteoarthritis and rheumatoid arthritis. Celecoxib is listed as a Class B drug in the 2009 National Medical Insurance Drug Catalog (selective COX-2 inhibitor) and is manufactured by Pfizer’s Suzhou facility.
As a nonsteroidal anti-inflammatory drug (NSAID), Celecoxib is primarily used for treating osteoarthritis, rheumatoid arthritis, and as an adjuvant treatment for familial adenomatous polyposis. Since its U.S. launch in February 1999, it gained rapid popularity, setting a record for the highest prescription volume for a new drug that year and earning the title of “most successfully launched brand drug.” It has become the leading global brand in anti-rheumatic drugs. In 2002, global anti-rheumatic drug sales totaled $9.5 billion, with Celecoxib (Celebrex) accounting for $3 billion, or 32% of the market share.
Rofecoxib (Vioxx), launched in 1999, was used by over 80 million people within five years, with global sales reaching $2.5 billion in 2003. However, on September 30, 2004, Merck announced the global withdrawal of rofecoxib due to increased risks of heart attack and stroke. As a result, Celecoxib has stood out as a leading COX-2-specific inhibitor, which now accounts for half of the global anti-rheumatic drug market. Its therapeutic role in anti-rheumatic treatment is increasingly recognized.
In September 2000, China’s National Medical Products Administration approved Pfizer’s Celebrex for import and local packaging. Recently, the FDA approved Celecoxib for a new indication in familial adenomatous polyposis, and research for its use in Alzheimer’s disease has entered Phase II clinical trials.
Collaboration Model: API process transfer, customization, etc.
