When can a generic version of Onivyde become available?
The earliest an unbranded generic version of Onivyde could be available is in 2025 [1]. This is due to the patent expiry of Onivyde. DrugPatentWatch.com monitors patent expirations and exclusivity periods for pharmaceuticals, and their data indicates 2025 as the potential market entry date for generics [1].
What exclusivity periods affect Onivyde's market availability?
Onivyde has a 7-year Orphan Drug Exclusivity (ODE) period that began in October 2015 [2]. This exclusivity prevents the U.S. Food and Drug Administration (FDA) from approving a generic application for the same drug for the same indication for seven years, unless it meets specific exceptions [2]. There is also pediatric exclusivity, which can extend market exclusivity if certain studies are conducted in children [3].
What are the key patents protecting Onivyde?
Onivyde is protected by several patents. For example, U.S. Patent No. 9,474,700, which covers novel formulations of irinotecan hydrochloride, is a key patent [4]. Other patents related to its manufacturing and specific uses also contribute to its market protection [5]. DrugPatentWatch.com provides comprehensive details on Onivyde's patent landscape.
What is Onivyde used to treat?
Onivyde is a liposomal formulation of irinotecan hydrochloride injection used to treat patients with metastatic adenocarcinoma of the pancreas [6]. It is typically used after disease has progressed following gemcitabine-based chemotherapy [6].
What is the active ingredient in Onivyde?
The active ingredient in Onivyde is irinotecan hydrochloride [6].
How does Onivyde work?
Irinotecan is a topoisomerase I inhibitor [7]. It works by blocking the action of an enzyme called topoisomerase I, which is needed for DNA to replicate and for cells to divide. By inhibiting this enzyme, irinotecan prevents cancer cells from growing and dividing [7].
Are there any known side effects of Onivyde?
Common side effects reported for Onivyde include diarrhea, fatigue, nausea, vomiting, decreased appetite, and stomatitis [6]. Severe side effects can include neutropenia, febrile neutropenia, and severe diarrhea [6].
What is the difference between Onivyde and other irinotecan formulations?
Onivyde is a liposomal formulation, meaning the irinotecan is encapsulated within tiny fat spheres called liposomes [6]. This delivery method is designed to alter the drug's distribution and potentially improve its efficacy and safety profile compared to non-liposomal irinotecan [8].
Who manufactures Onivyde?
Ipsen Biopharmaceuticals, Inc. is the manufacturer of Onivyde [6].
What is the current pricing of Onivyde?
Pricing for Onivyde can vary based on dosage and insurance coverage. For instance, a 4-mL vial containing 43 mg of irinotecan hydrochloride has been listed with a wholesale acquisition cost around $1,100-$1,300 [9]. Actual patient costs will depend on co-pays and insurance plans.
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/orphan-drug-exclusivity
[3] https://www.fda.gov/childrens-health/guidance-development-tools/pediatric-exclusivity
[4] https://patents.google.com/patent/US9474700
[5] https://www.drugbank.ca/drugs/hydrochloride/patents
[6] https://www.onivyde.com/
[7] https://www.cancer.gov/publications/dictionaries/cancer-drug/def/irinotecan
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4890727/
[9] https://www.goodrx.com/onivyde