LUTATHERA Drug Patent Profile

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

Lutathera is a drug marketed by Aaa Usa Inc and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-three patent family members in thirteen countries.

The generic ingredient in LUTATHERA is lutetium dotatate lu-177. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium dotatate lu-177 profile page.

DrugPatentWatch^® Generic Entry Outlook for Lutathera

Lutathera was eligible for patent challenges on January 26, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 25, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUTATHERA

International Patents:	23
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	31
Drug Prices:	Drug price information for LUTATHERA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUTATHERA
What excipients (inactive ingredients) are in LUTATHERA?	LUTATHERA excipients list
DailyMed Link:	LUTATHERA at DailyMed

See drug prices for LUTATHERA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for LUTATHERA

NDA:

208700

Dosage:

SOLUTION;INTRAVENOUS

^*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 LUTATHERA

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

Sponsor	Phase
Providence Health & Services	Phase 1
Exelixis	Phase 1
Advanced Accelerator Applications SA	Phase 1

See all LUTATHERA clinical trials

US Patents and Regulatory Information for LUTATHERA

LUTATHERA is protected by two US patents and two FDA Regulatory Exclusivities.

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 LUTATHERA

FDA Regulatory Exclusivity protecting LUTATHERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aaa Usa Inc	LUTATHERA	lutetium dotatate lu-177	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes			Y
Aaa Usa Inc	LUTATHERA	lutetium dotatate lu-177	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes
Aaa Usa Inc	LUTATHERA	lutetium dotatate lu-177	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes			Y
Aaa Usa Inc	LUTATHERA	lutetium dotatate lu-177	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes

International Patents for LUTATHERA

When does loss-of-exclusivity occur for LUTATHERA?

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

Argentina

Australia

Brazil

China

Colombia

European Patent Office

Germany

Israel

Japan

Singapore

South Korea

Taiwan

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 LUTATHERA around the world.

Country	Patent Number	Title	Estimated Expiration
Colombia	2021000506	Soluciones de complejos de radionúclidos estables y concentradas
Japan	2022500355	安定な濃厚放射性核種錯体溶液
World Intellectual Property Organization (WIPO)	2020021322
China	112955188	治疗神经内分泌肿瘤的方法 (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS)
European Patent Office	3826687	PROCÉDÉ DE TRAITEMENT DE TUMEURS NEUROENDOCRINES (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS)