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Last Updated: May 20, 2022

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.

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

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Summary for LUTATHERA
Drug patent expirations by year for LUTATHERA
Drug Prices for LUTATHERA

See drug prices for LUTATHERA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for LUTATHERA
Generic Entry Date for LUTATHERA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Providence Health & ServicesPhase 1
ExelixisPhase 1
Advanced Accelerator Applications SAPhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LUTATHERA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable, concentrated radionuclide complex solutions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting LUTATHERA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Aaa Usa Inc LUTATHERA lutetium dotatate lu-177 SOLUTION;INTRAVENOUS 208700-001 Jan 26, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aaa Usa Inc LUTATHERA lutetium dotatate lu-177 SOLUTION;INTRAVENOUS 208700-001 Jan 26, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Aaa Usa Inc LUTATHERA lutetium dotatate lu-177 SOLUTION;INTRAVENOUS 208700-001 Jan 26, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 18433575
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2021001148
Estimated Expiration: See Plans and Pricing

China

Patent: 2584875
Estimated Expiration: See Plans and Pricing

Patent: 2867512
Estimated Expiration: See Plans and Pricing

Patent: 2955188
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 21000506
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 26686
Estimated Expiration: See Plans and Pricing

Patent: 26687
Estimated Expiration: See Plans and Pricing

Patent: 56262
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2018006567
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0314
Estimated Expiration: See Plans and Pricing

Japan

Patent: 21531306
Estimated Expiration: See Plans and Pricing

Patent: 22500355
Estimated Expiration: See Plans and Pricing

Patent: 22501313
Estimated Expiration: See Plans and Pricing

Patent: 22502505
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 202100645X
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 210035855
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 2019489
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
Japan 2022500355 安定な濃厚放射性核種錯体溶液 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2020021322 See Plans and Pricing
China 112955188 治疗神经内分泌肿瘤的方法 (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS) See Plans and Pricing
European Patent Office 3826687 PROCÉDÉ DE TRAITEMENT DE TUMEURS NEUROENDOCRINES (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Boehringer Ingelheim
McKesson
Colorcon
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.