See the DrugPatentWatch profile for Onivyde
Onivyde (nal-IRI) is an encapsulated formulation of irinotecan, a topoisomerase I inhibitor [1]. It is approved for use in combination with fluorouracil and leucovorin for patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy [1].
How does Onivyde work?
Onivyde's active ingredient is irinotecan, which is delivered in a liposomal encapsulation. This liposomal delivery system is designed to improve the drug's pharmacokinetics, potentially leading to increased drug concentration at the tumor site and reduced systemic toxicity compared to irinotecan alone [1]. Once in the body, the liposomes release irinotecan, which then inhibits topoisomerase I, an enzyme crucial for DNA replication and cell division. This inhibition leads to DNA damage and ultimately to cancer cell death [1].
When does Onivyde's patent protection end?
The patent landscape for Onivyde is complex and can involve multiple patents covering the drug substance, formulation, manufacturing, and methods of use. According to DrugPatentWatch.com, specific patent expiry dates can vary [2]. Generally, the duration of market exclusivity for a drug is influenced by its patent protection, regulatory exclusivities, and any potential legal challenges [3].
What are the alternatives to Onivyde for pancreatic cancer?
For patients with metastatic pancreatic cancer who have progressed on gemcitabine-based therapy, treatment options may include other chemotherapy regimens, targeted therapies, or immunotherapy, depending on the specific genetic makeup of the tumor and the patient's overall health [4]. Some patients may also be candidates for clinical trials investigating novel treatments [4].
What are the side effects of Onivyde?
The most common side effects associated with Onivyde, when used in combination with fluorouracil and leucovorin, include diarrhea, fatigue, nausea, vomiting, decreased appetite, and stomatitis [1]. Severe side effects can include severe diarrhea, neutropenia, and hypersensitivity reactions [1]. Patients should discuss potential side effects and their management with their healthcare provider [1].
Who manufactures Onivyde?
Onivyde is manufactured by Ipsen Biopharmaceuticals, Inc. [1].
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Sources:
[1] https://www.onivyde.com/
[2] https://www.drugpatentwatch.com/
[3] https://www.drugpatentwatch.com/about/drug-patent-explained
[4] https://www.cancer.gov/types/pancreatic