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LUTATHERA Drug Patent Profile

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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 and one Paragraph IV challenge.

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

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

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for LUTATHERA

International Patents:	33
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	39
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

Drug patent expirations by year for LUTATHERA

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

Generic Entry Date for LUTATHERA^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
University of Chicago	Phase 1/Phase 2
Merck Sharp & Dohme LLC	Phase 2
Pashtoon M. Kasi	Phase 2

See all LUTATHERA clinical trials

Paragraph IV (Patent) Challenges for LUTATHERA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUTATHERA	Injection	lutetium lu 177 dotatate	10 mCi/mL	208700	1	2023-11-13

US Patents and Regulatory Information for LUTATHERA

LUTATHERA is protected by two US patents and one FDA Regulatory Exclusivity.

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

This potential generic entry date is based on patent ⤷ Try a 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.

Patents protecting LUTATHERA

Stable, concentrated radionuclide complex solutions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting LUTATHERA

TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS
Exclusivity Expiration: ⤷ Try a Trial

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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
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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 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

Patent: 9655
Estimated Expiration: ⤷ Try a Trial

Australia

Patent: 18433575
Estimated Expiration: ⤷ Try a Trial

Patent: 22203683
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2021001148
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 53630
Estimated Expiration: ⤷ Try a Trial

China

Patent: 2584875
Estimated Expiration: ⤷ Try a Trial

Patent: 2867512
Estimated Expiration: ⤷ Try a Trial

Patent: 2955188
Estimated Expiration: ⤷ Try a Trial

Patent: 7122707
Estimated Expiration: ⤷ Try a Trial

Colombia

Patent: 21000506
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 26686
Estimated Expiration: ⤷ Try a Trial

Patent: 26687
Estimated Expiration: ⤷ Try a Trial

Patent: 56262
Estimated Expiration: ⤷ Try a Trial

Germany

Patent: 2018006567
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 0314
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 58451
Estimated Expiration: ⤷ Try a Trial

Patent: 58484
Estimated Expiration: ⤷ Try a Trial

Patent: 02218
Estimated Expiration: ⤷ Try a Trial

Patent: 21531306
Estimated Expiration: ⤷ Try a Trial

Patent: 22500355
Estimated Expiration: ⤷ Try a Trial

Patent: 22501313
Estimated Expiration: ⤷ Try a Trial

Patent: 22502505
Estimated Expiration: ⤷ Try a Trial

Patent: 23107801
Estimated Expiration: ⤷ Try a Trial

Patent: 23117417
Estimated Expiration: ⤷ Try a Trial

Patent: 23126209
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 21000805
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 202100645X
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 210035855
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 2019489
Estimated Expiration: ⤷ Try a 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 LUTATHERA around the world.

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Country	Patent Number	Title	Estimated Expiration
China	112584875	稳定的、浓缩的放射性核素络合物溶液 (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS)	⤷ Try a Trial
Japan	7358451		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2020021465		⤷ Try a Trial
Argentina	119655	SOLUCIONES DE COMPLEJOS DE RADIONÚCLIDOS ESTABLES Y CONCENTRADAS	⤷ Try a Trial
Japan	2022502505	併用療法	⤷ Try a Trial
European Patent Office	3826687	PROCÉDÉ DE TRAITEMENT DE TUMEURS NEUROENDOCRINES (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration