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Last Updated: December 23, 2024

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.
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 ActionAndrogen 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:RXDosage:CAPSULE;ORALStrength112.5MG
Approval Date:Mar 28, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 28, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  SubscribePatent Expiration:Nov 30, 2030Product 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:⤷  SubscribePatent Expiration:Nov 30, 2030Product 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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