Details for New Drug Application (NDA): 208088
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NDA 208088 describes TLANDO, which is a drug marketed by Verity and is included in one NDA. It is available from two suppliers. There are thirteen patents protecting this drug. Additional details are available on the TLANDO profile page.
The generic ingredient in TLANDO 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.
The generic ingredient in TLANDO 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 208088
| Tradename: | TLANDO |
| Applicant: | Verity |
| Ingredient: | testosterone undecanoate |
| Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208088
Generic Entry Date for 208088*:
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: 208088
| Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 208088
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TLANDO | testosterone undecanoate | CAPSULE;ORAL | 208088 | NDA | Antares Pharma, Inc. | 54436-112 | 54436-112-20 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (54436-112-20) |
| TLANDO | testosterone undecanoate | CAPSULE;ORAL | 208088 | NDA | Verity Pharmaceuticals Inc. | 74676-0112 | 74676-0112-2 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (74676-0112-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 112.5MG | ||||
| Approval Date: | Mar 28, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 30, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 30, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). | ||||||||
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