Generic Kyzatrex Availability
Last updated on Jan 8, 2025.
Kyzatrex is a brand name of testosterone, approved by the FDA in the following formulation(s):
KYZATREX (testosterone undecanoate - capsule;oral)
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Manufacturer: MARIUS PHARMS LLC
Approval date: July 27, 2022
Strength(s): 100MG [RLD], 150MG [RLD], 200MG [RLD]
Has a generic version of Kyzatrex been approved?
An Authorized Generic version of Kyzatrex has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.
List of authorized generic versions:
- Testosterone Undecanoate ORAL CAPSULE 200 mg
Trifluent Pharma LLC
NDC Code: 733520105
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kyzatrex. 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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Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Patent 10,576,089
Issued: March 3, 2020
Inventor(s): Dhingra Om
Assignee(s): Marius Pharmaceuticals LLCA formulation for drug delivery, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of a lipophilic therapeutic agent by formulation with sterols and/or sterol esters, resulting in higher bioavailability of a therapeutic agent administered to a subject in need of such therapeutic agent. The formulation contains a therapeutic agent and a sterol or sterol ester, and can, optionally, further contain a solubilizer and/or an enhancing agent. Also described are pharmaceutical compositions containing the formulations and methods of making and methods of using the formulations and pharmaceutical compositions. Formulations of the disclosure can be constituted to minimize the synthesis of dihydrotestosterone when the therapeutic agent includes testosterone or testosterone esters.
Patent expiration dates:
- December 31, 2030✓✓
- December 31, 2030
-
Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Patent 10,576,090
Issued: March 3, 2020
Inventor(s): Dhingra Om
Assignee(s): Marius Pharmaceuticals LLCA formulation for drug delivery, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of a lipophilic therapeutic agent by formulation with sterols and/or sterol esters, resulting in higher bioavailability of a therapeutic agent administered to a subject in need of such therapeutic agent. The formulation contains a therapeutic agent and a sterol or sterol ester, and can, optionally, further contain a solubilizer and/or an enhancing agent. Also described are pharmaceutical compositions containing the formulations and methods of making and methods of using the formulations and pharmaceutical compositions. Formulations of the disclosure can be constituted to minimize the synthesis of dihydrotestosterone when the therapeutic agent includes testosterone or testosterone esters.
Patent expiration dates:
- December 31, 2030✓
- December 31, 2030
-
Patent 11,590,146
Patent expiration dates:
- December 31, 2030✓
- December 31, 2030
-
Patent 11,617,758
Patent expiration dates:
- March 15, 2033✓✓
- March 15, 2033
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:
- July 27, 2025 - NEW PRODUCT
More about Kyzatrex (testosterone)
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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.