Details for New Drug Application (NDA): 213953
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NDA 213953 describes KYZATREX, which is a drug marketed by Marius Pharms Llc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the KYZATREX profile page.
The generic ingredient in KYZATREX is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
The generic ingredient in KYZATREX is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Five 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 |
| Formulation / Manufacturing: | see details |
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 | Marius Pharmaceuticals | 80603-101 | 80603-101-11 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-11) |
| KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953 | NDA | Marius Pharmaceuticals | 80603-101 | 80603-101-22 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-22) |
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: | ⤷ Try a Trial | Patent Expiration: | Dec 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING TESTOSTERONE DEFICIENCY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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