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Last Updated: April 22, 2024

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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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Drug patent expirations by year for LUTATHERA
Drug Prices for LUTATHERA

See drug prices for LUTATHERA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
University of ChicagoPhase 1/Phase 2
Merck Sharp & Dohme LLCPhase 2
Pashtoon M. KasiPhase 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

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

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.

Country Patent Number Title Estimated Expiration
Japan 7402218 ⤷  Try a Trial
China 112867512 联合疗法 (Combination therapy) ⤷  Try a Trial
European Patent Office 3826686 SOLUTIONS COMPLEXES CONCENTRÉES STABLES DE RADIONUCLÉIDES (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS) ⤷  Try a Trial
Japan 2023117417 安定な濃厚放射性核種錯体溶液 (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS) ⤷  Try a Trial
Argentina 119655 SOLUCIONES DE COMPLEJOS DE RADIONÚCLIDOS ESTABLES Y CONCENTRADAS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.