TLANDO Drug Patent Profile

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Which patents cover Tlando, and when can generic versions of Tlando launch?

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

This drug has thirty-eight patent family members in sixteen countries.

The generic ingredient in TLANDO is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Four 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 January 8, 2029. 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:	38
US Patents:	14
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for TLANDO

TLANDO is protected by fifteen US patents.

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

This potential generic entry date is based on patent 11,304,960.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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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	12,310,978	⤷ Start Trial				⤷ Start Trial
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	10,716,794	⤷ Start Trial				⤷ Start Trial
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	11,364,249	⤷ Start Trial				⤷ Start Trial
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	10,226,473	⤷ Start Trial				⤷ Start Trial
>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

When does loss-of-exclusivity occur for TLANDO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5538
Patent: COMPOSICIONES FARMACÉUTICAS DE ÉSTERES DE TESTOSTERONA DE CADENA LARGA LIPOEQUILIBRADOS PARA LA ADMINISTRACIÓN ORAL
Estimated Expiration: ⤷ Start Trial

Australia

Patent: 10203457
Patent: Steroidal compositions
Estimated Expiration: ⤷ Start Trial

Patent: 14232475
Patent: Lipobalanced long chain testosterone esters for oral delivery
Estimated Expiration: ⤷ Start Trial

Patent: 19200097
Patent: Lipobalanced long chain testosterone esters for oral delivery
Estimated Expiration: ⤷ Start Trial

Brazil

Patent: 2015020849
Patent: ésteres de testosterona de cadeia longa lipobalanceados para entrega oral
Estimated Expiration: ⤷ Start Trial

Patent: 1007025
Patent: composições esteroidais
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 44266
Patent: COMPOSITIONS STEROIDIENNES (STEROIDAL COMPOSITIONS)
Estimated Expiration: ⤷ Start Trial

Patent: 42005
Patent: ESTERS DE TESTOSTERONE A LONGUE CHAINE LIPOEQUILIBRES POUR UNE ADMINISTRATION ORALE (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY)
Estimated Expiration: ⤷ Start Trial

China

Patent: 2271665
Estimated Expiration: ⤷ Start Trial

Patent: 5073118
Patent: Lipobalanced long chain testosterone esters for oral delivery
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 73295
Patent: COMPOSITIONS STÉROÏDIENNES (STEROIDAL COMPOSITIONS)
Estimated Expiration: ⤷ Start Trial

Patent: 68363
Patent: ESTERS DE TESTOSTÉRONE À LONGUE CHAÎNE LIPOÉQUILIBRÉS POUR UNE ADMINISTRATION ORALE (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY)
Estimated Expiration: ⤷ Start Trial

Patent: 78368
Patent: COMPOSITIONS STÉROÏDIENNES (STEROIDAL COMPOSITIONS)
Estimated Expiration: ⤷ Start Trial

Patent: 97762
Patent: ESTERS DE TESTOSTÉRONE À LONGUE CHAÎNE LIPOÉQUILIBRÉS POUR UNE ADMINISTRATION ORALE (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY)
Estimated Expiration: ⤷ Start Trial

Israel

Patent: 0958
Patent: אסתרים מאוזנים וארוכי שרשרת של טסטוסטרון למתן אוראלי (Lipobalanced long chain testosterone esters for oral delivery)
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 58812
Estimated Expiration: ⤷ Start Trial

Patent: 07711
Estimated Expiration: ⤷ Start Trial

Patent: 12514653
Patent: ステロイド組成物
Estimated Expiration: ⤷ Start Trial

Patent: 15120700
Patent: ステロイド組成物 (STEROIDAL COMPOSITIONS)
Estimated Expiration: ⤷ Start Trial

Patent: 16514706
Patent: 経口送達用リポバランス長鎖テストステロンエステル
Estimated Expiration: ⤷ Start Trial

Mexico

Patent: 11007351
Patent: COMPOSICIONES ESTEROIDALES. (STEROIDAL COMPOSITIONS.)
Estimated Expiration: ⤷ Start Trial

Patent: 15010594
Patent: ESTERES DE TESTOSTERONA DE CADENA LARGA LIPOBALANCEADOS PARA SUMINISTRO ORAL. (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY.)
Estimated Expiration: ⤷ Start Trial

Russian Federation

Patent: 22592
Patent: ДЛИННОЦЕПОЧЕЧНЫЕ ЛИПОСБАЛАНСИРОВАННЫЕ СЛОЖНЫЕ ЭФИРЫ ТЕСТОСТЕРОНА ДЛЯ ПЕРОРАЛЬНОЙ ДОСТАВКИ (LONG-CHAIN LIPOSBALANCED ESTERS OF TESTOSTERONE FOR ORAL DELIVERY)
Estimated Expiration: ⤷ Start Trial

Patent: 15128028
Patent: ДЛИННОЦЕПОЧЕЧНЫЕ ЛИПОСБАЛАНСИРОВАННЫЕ СЛОЖНЫЕ ЭФИРЫ ТЕСТОСТЕРОНА ДЛЯ ПЕРОРАЛЬНОЙ ДОСТАВКИ (LONG-CHAIN LIPOSBALANCED ESTERS OF TESTOSTERONE FOR ORAL DELIVERY)
Estimated Expiration: ⤷ Start Trial

South Africa

Patent: 1507700
Patent: LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 2238478
Estimated Expiration: ⤷ Start Trial

Patent: 150129671
Patent: 구강 전달용 지방균형잡힌 장쇄 테스토스테론 에스테르 (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY)
Estimated Expiration: ⤷ Start Trial

Spain

Patent: 73490
Estimated Expiration: ⤷ Start Trial

Taiwan

Patent: 1521731
Patent: Lipobalanced long chain testosterone esters for oral delivery
Estimated Expiration: ⤷ Start Trial

Uruguay

Patent: 445
Patent: ÉSTERES DE TESTOSTERONA DE CADENA LARGA LIPOEQUILIBRADOS PARA LA ADMINISTRACIÓN ORAL
Estimated Expiration: ⤷ Start Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012075081		⤷ Start Trial
Argentina	095538		⤷ Start Trial
Australia	2010203457		⤷ Start Trial
Australia	2014232475		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

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Questions you can ask:

Summary for TLANDO

When does loss-of-exclusivity occur for TLANDO?

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