Generic Defitelio Availability
Last updated on Apr 10, 2025.
Defitelio is a brand name of defibrotide, approved by the FDA in the following formulation(s):
DEFITELIO (defibrotide sodium - solution;intravenous)
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Manufacturer: JAZZ PHARMS INC
Approval date: March 30, 2016
Strength(s): 200MG/2.5ML (80MG/ML) [RLD]
Is there a generic version of Defitelio available?
No. There is currently no therapeutically equivalent version of Defitelio available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Defitelio. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Euglobulin-based method for determining the biological activity of defibrotide
Patent 11,085,043
Issued: August 10, 2021
Inventor(s): Ignoni Terenzio & Kumar Vijay & Islam Khalid
Assignee(s): GENTIUM S.R.L.It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.
Patent expiration dates:
- June 22, 2032✓
- June 22, 2032
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Euglobulin-based method for determining the biological activity of defibrotide
Patent 11,236,328
Issued: February 1, 2022
Inventor(s): Ignoni Terenzio & Kumar Vijay & Islam Khalid
Assignee(s): GENTIUM S.R.L.It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.
Patent expiration dates:
- June 22, 2032✓
- June 22, 2032
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Euglobulin-based method for determining the biological activity of defibrotide
Patent 11,746,348
Issued: September 5, 2023
Inventor(s): Ignoni; Terenzio et al.
Assignee(s): GENTIUM S.R.L. (Villa Guardia, IT)It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.
Patent expiration dates:
- June 22, 2032✓
- June 22, 2032
More about Defitelio (defibrotide)
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- FDA approval history
- Drug class: miscellaneous coagulation modifiers
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.