Details for New Drug Application (NDA): 213953
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The generic ingredient in KYZATREX is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
Summary for 213953
Tradename: | KYZATREX |
Applicant: | Marius Pharms Llc |
Ingredient: | testosterone undecanoate |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213953
Generic Entry Date for 213953*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 213953
Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 213953
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953 | NDA AUTHORIZED GENERIC | Trifluent Pharma LLC | 73352-105 | 73352-105-22 | 120 CAPSULE in 1 BOTTLE (73352-105-22) |
KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953 | NDA | Marius Pharmaceuticals | 80603-101 | 80603-101-11 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 27, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jul 27, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Dec 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING TESTOSTERONE DEFICIENCY | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Dec 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? |
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