Generic DefenCath Availability
Last updated on Jan 8, 2025.
DefenCath is a brand name of heparin/taurolidine, approved by the FDA in the following formulation(s):
DEFENCATH (heparin sodium; taurolidine - solution;n/a)
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Manufacturer: CORMEDIX
Approval date: November 15, 2023
Strength(s): 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) [RLD], 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) [RLD]
Has a generic version of DefenCath been approved?
No. There is currently no therapeutically equivalent version of DefenCath available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of DefenCath. 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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Patent 11,738,120
Patent expiration dates:
- April 15, 2042✓✓
- April 15, 2042
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Patent 7,696,182
Patent expiration dates:
- May 16, 2025✓✓✓
- May 16, 2025
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Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
Patent 8,541,393
Issued: September 24, 2013
Inventor(s): Prosl Frank R.
Assignee(s): ND Partners, LLCThe present invention relates to inhibiting or preventing infection and protecting against patency complications after a blood catheter has been inserted in a patient comprising administering to the device a pharmaceutically effective amount of a composition comprising (A) at least one taurinamide derivative, (B) at least one compound selected from the group consisting of biologically acceptable acids and biologically acceptable salts thereof; and (C) heparin at a low concentration.
Patent expiration dates:
- November 2, 2024✓✓✓
- November 2, 2024
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Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
Patent 9,339,036
Issued: May 17, 2016
Inventor(s): Prosl Frank R.
Assignee(s): ND Partners, LLCThe present invention relates to inhibiting or preventing infection and protecting against patency complications after a blood catheter has been inserted in a patient comprising administering to the device a pharmaceutically effective amount of a composition comprising (A) at least one taurinamide derivative, and (B) heparin at a low concentration.
Patent expiration dates:
- November 2, 2024✓✓
- November 2, 2024
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- November 15, 2028 - NEW CHEMICAL ENTITY
- November 15, 2033 - GENERATING ANTIBIOTIC INCENTIVES NOW
More about DefenCath (heparin / taurolidine)
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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.
