See the DrugPatentWatch profile for Defitelio
Defitelio (defibrotide) has a composition of matter patent in the United States [1]. This patent protects the drug substance itself.
When does the Defitelio composition of matter patent expire?
The primary composition of matter patent for defibrotide in the United States expired in February 2024 [1].
What other patents protect Defitelio?
Beyond the composition of matter patent, Defitelio is also protected by other patents. These include method of use patents, which cover specific ways the drug can be administered or used to treat certain conditions [1]. For instance, there are patents related to its use in treating veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), in patients undergoing hematopoietic stem cell transplantation [1][2]. These method of use patents may extend beyond the expiration of the composition of matter patent.
Can generic defibrotide be developed before all patents expire?
The ability to develop and market generic versions of defibrotide depends on the expiration of all relevant patents, not just the composition of matter patent [1]. Method of use patents can prevent generic manufacturers from marketing their products for the approved indications, even if the patent on the drug substance itself has expired [1]. This often leads to complex legal challenges and settlements.
How do companies challenge drug patents?
Companies seeking to develop generic drugs often challenge existing patents through various legal mechanisms. This can involve arguing that the patent is invalid or that their product does not infringe on the patent claims [3]. These challenges can lead to patent litigation, which may result in settlements allowing for an earlier market entry for generic versions [3].
What is defibrotide used for?
Defibrotide is a pharmaceutical product approved for the treatment of severe VOD/SOS in adult and pediatric patients who have undergone a hematopoietic stem cell transplant [2]. It works by restoring a healthier balance of pro-coagulant and anti-coagulant factors, thereby increasing fibrinolysis and improving microvascular blood flow [2].
Who makes Defitelio?
Defitelio is manufactured and marketed by Jazz Pharmaceuticals [4].
What are the risks associated with Defitelio?
The prescribing information for Defitelio lists several potential risks. These include hypersensitivity reactions, such as anaphylaxis, which can occur during or after infusion. Bleeding is another significant risk, as defibrotide can affect blood clotting [2]. Patients may also experience fluid overload, and there is a theoretical risk of thrombosis [2].
How does Defitelio compare to other treatments for VOD/SOS?
Historically, the management of severe VOD/SOS has been challenging, with limited treatment options and high mortality rates. Defibrotide represented a significant advancement in treating this condition. Other supportive care measures, such as fluid management and organ support, are still crucial in managing patients with VOD/SOS [2].
What is the regulatory status of defibrotide?
Defibrotide has received marketing authorization from regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for its approved indication [2][4].
Sources:
[1] https://www.uspto.gov/
[2] https://www.jazzpharma.com/
[3] https://www.law.cornell.edu/
[4] https://www.ema.europa.eu/