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TLANDO Drug Patent Profile

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When do Tlando patents expire, and what generic alternatives are available?

Tlando is a drug marketed by Verity and is included in one NDA. There are thirteen patents protecting this drug.

This drug has thirty-six patent family members in fifteen countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Tlando

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 28, 2025. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for TLANDO

International Patents:	36
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	1
Patent Applications:	1,450
Drug Prices:	Drug price information for TLANDO
What excipients (inactive ingredients) are in TLANDO?	TLANDO excipients list
DailyMed Link:	TLANDO at DailyMed

Drug patent expirations by year for TLANDO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TLANDO

Generic Entry Date for TLANDO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW PRODUCT NDA: 208088 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.

Recent Clinical Trials for TLANDO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lipocine Inc.	Phase 3

See all TLANDO clinical trials

Pharmacology for TLANDO

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for TLANDO

TLANDO is protected by fourteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TLANDO is ⤷ Sign Up.

This potential generic entry date is based on NEW PRODUCT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TLANDO

High-strength testosterone undecanoate compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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).

Steroidal compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHODS OF ADMINISTERING TESTOSTERONE UNDECANOATE FOR RESTORING TESTOSTERONE CONCENTRATION IN A HYPOGONADAL MALE SUBJECT

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHODS OF CONTINUING OR DISCONTINUING A DOSAGE REGIMEN OF A TESTOSTERONE UNDECANOATE PHARMACEUTICAL COMPOSITION TO A HYPOGONADAL MALE SUBJECT

FDA Regulatory Exclusivity protecting TLANDO

NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for TLANDO

See the table below for patents covering TLANDO around the world.

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Country	Patent Number	Title	Estimated Expiration
Brazil	112015020849	ésteres de testosterona de cadeia longa lipobalanceados para entrega oral	⤷ Sign Up
Taiwan	201521731	Lipobalanced long chain testosterone esters for oral delivery	⤷ Sign Up
Japan	2016514706	経口送達用リポバランス長鎖テストステロンエステル	⤷ Sign Up
Japan	2015120700	ステロイド組成物 (STEROIDAL COMPOSITIONS)	⤷ Sign Up
Japan	2012514653		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration