Details for New Drug Application (NDA): 206089
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NDA 206089 describes JATENZO, which is a drug marketed by Tolmar and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the JATENZO profile page.
The generic ingredient in JATENZO 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 JATENZO 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 206089
| Tradename: | JATENZO |
| Applicant: | Tolmar |
| Ingredient: | testosterone undecanoate |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206089
Generic Entry Date for 206089*:
Constraining patent/regulatory exclusivity:
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: 206089
| Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 206089
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089 | NDA | TOLMAR Inc. | 69087-158 | 69087-158-12 | 12 BOTTLE, PLASTIC in 1 BOX (69087-158-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
| JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089 | NDA | TOLMAR Inc. | 69087-198 | 69087-198-12 | 12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 158MG | ||||
| Approval Date: | Mar 27, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 10,543,219 | Patent Expiration: | Apr 12, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING TESTOSTERONE DEFICIENCY | ||||||||
| Patent: | 10,617,696 | Patent Expiration: | Apr 12, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 11,179,402 | Patent Expiration: | Apr 14, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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