Lutetium lu 177 dotatate - Generic Drug Details

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What are the generic sources for lutetium lu 177 dotatate and what is the scope of patent protection?

Lutetium lu 177 dotatate is the generic ingredient in one branded drug marketed by Aaa Usa Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lutetium lu 177 dotatate has thirty-eight patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for lutetium lu 177 dotatate

International Patents:	38
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	19
Patent Applications:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lutetium lu 177 dotatate
What excipients (inactive ingredients) are in lutetium lu 177 dotatate?	lutetium lu 177 dotatate excipients list
DailyMed Link:	lutetium lu 177 dotatate at DailyMed

Recent Clinical Trials for lutetium lu 177 dotatate

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 2
Pashtoon M. Kasi	Phase 2
GI Research Foundation	Phase 2

See all lutetium lu 177 dotatate clinical trials

Paragraph IV (Patent) Challenges for LUTETIUM LU 177 DOTATATE

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 lutetium lu 177 dotatate

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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 lutetium lu 177 dotatate

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Country	Patent Number	Title	Estimated Expiration
Australia	2024201217	Stable, concentrated radionuclide complex solutions	⤷ Sign Up
Japan	2022502505	併用療法	⤷ Sign Up
Mexico	2021000805	SOLUCIONES DE COMPLEJOS DE RADIONUCLIDOS ESTABLES Y CONCENTRADAS. (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS.)	⤷ Sign Up
Australia	2018433575	Stable, concentrated radionuclide complex solutions	⤷ Sign Up
Japan	7358451		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for lutetium lu 177 dotatate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4095130	LUC00352	Luxembourg	⤷ Sign Up	PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212
4095130	301281	Netherlands	⤷ Sign Up	PRODUCT NAME: LUTETIUM (177-LU)-VIPIVOTIDE TETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703, 20221212
4095130	CA 2024 00027	Denmark	⤷ Sign Up	PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDETETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212
4095130	2024C/528	Belgium	⤷ Sign Up	PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212
4095130	122024000038	Germany	⤷ Sign Up	PRODUCT NAME: (177LU)LUTETIUMVIPIVOTIDTETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703 20221209
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.