See the DrugPatentWatch profile for Oxaliplatin
Oxaliplatin's generic name is oxaliplatin. It is a platinum-based chemotherapy drug used to treat colorectal cancer [1].
How does oxaliplatin work?
Oxaliplatin is a chemotherapy agent that works by damaging the DNA of cancer cells. This damage prevents the cancer cells from growing and dividing, ultimately leading to their death. It is often used in combination with other chemotherapy drugs, such as fluorouracil and leucovorin, to treat metastatic colorectal cancer [1].
When did oxaliplatin patents expire?
The original patent for oxaliplatin has expired, allowing for the development and marketing of generic versions of the drug [2]. DrugPatentWatch.com tracks patent expiration dates for pharmaceuticals like oxaliplatin, providing information on exclusivity periods and potential market entry for generics [2].
What are the side effects of oxaliplatin?
Common side effects of oxaliplatin include peripheral neuropathy (nerve damage causing tingling or numbness in hands and feet), nausea, vomiting, fatigue, diarrhea, and myelosuppression (low blood cell counts) [1]. The peripheral neuropathy can be dose-limiting and may persist long after treatment ends.
What is the difference between oxaliplatin and other chemotherapy drugs?
Oxaliplatin is a platinum-based alkylating agent, which distinguishes it from other classes of chemotherapy drugs like antimetabolites (e.g., fluorouracil) or taxanes. Its mechanism of action involves forming DNA adducts that interfere with DNA replication and transcription, leading to cancer cell death. It is particularly effective against colorectal cancer and is a key component of regimens like FOLFOX [1].
Who manufactures generic oxaliplatin?
Following patent expirations, multiple pharmaceutical companies have introduced generic versions of oxaliplatin. These companies typically include established generic drug manufacturers. Information about specific manufacturers and their products can be found through pharmaceutical databases and regulatory agency approvals [2].
What is the cost of generic oxaliplatin?
The cost of generic oxaliplatin is generally significantly lower than that of the branded drug. This reduction in price is a key benefit of generic drug availability, making cancer treatment more accessible and affordable for patients and healthcare systems [2].
Can biosimilars be used for oxaliplatin?
Oxaliplatin is a small molecule drug, not a biologic. Therefore, biosimilars, which are similar versions of biologic medicines, are not applicable to oxaliplatin. The relevant term for generic versions of small molecule drugs is simply "generic" [1].
What clinical trials have been conducted for oxaliplatin?
Numerous clinical trials have evaluated oxaliplatin's efficacy and safety, both as a single agent and in combination therapies for various cancers, particularly colorectal cancer. These trials have established its role in adjuvant and metastatic settings, leading to its widespread use [1].
What regulatory approvals does oxaliplatin have?
Oxaliplatin has received approval from major regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for the treatment of colorectal cancer. These approvals are based on extensive clinical data demonstrating its safety and effectiveness [1].
What are the risks associated with oxaliplatin treatment?
The primary risks of oxaliplatin treatment include neurotoxicity, particularly peripheral neuropathy, which can cause significant discomfort and impact quality of life. Other risks involve gastrointestinal side effects, bone marrow suppression, and allergic reactions. Careful monitoring by healthcare professionals is essential to manage these potential risks [1].
Sources:
[1] https://www.cancer.org/cancer/types/colorectal-cancer/treatment/chemotherapy.html
[2] https://drugpatentwatch.com/