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Last Updated: February 29, 2024

Setmelanotide acetate - Generic Drug Details


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What are the generic sources for setmelanotide acetate and what is the scope of freedom to operate?

Setmelanotide acetate is the generic ingredient in one branded drug marketed by Rhythm and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Setmelanotide acetate has ninety-three patent family members in twenty-one countries.

One supplier is listed for this compound.

Summary for setmelanotide acetate
International Patents:93
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 23
Patent Applications: 82
DailyMed Link:setmelanotide acetate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for setmelanotide acetate
Generic Entry Date for setmelanotide acetate*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*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.

Pharmacology for setmelanotide acetate

US Patents and Regulatory Information for setmelanotide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhythm IMCIVREE setmelanotide acetate SOLUTION;SUBCUTANEOUS 213793-001 Nov 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rhythm IMCIVREE setmelanotide acetate SOLUTION;SUBCUTANEOUS 213793-001 Nov 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Rhythm IMCIVREE setmelanotide acetate SOLUTION;SUBCUTANEOUS 213793-001 Nov 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rhythm IMCIVREE setmelanotide acetate SOLUTION;SUBCUTANEOUS 213793-001 Nov 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Rhythm IMCIVREE setmelanotide acetate SOLUTION;SUBCUTANEOUS 213793-001 Nov 25, 2020 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 setmelanotide acetate

Country Patent Number Title Estimated Expiration
South Korea 20080049711 MELANOCORTIN RECEPTOR LIGANDS ⤷  Try a Trial
European Patent Office 3778623 COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
Japan 6538025 ⤷  Try a Trial
European Patent Office 2286825 Ligands des récépteurs de la mélanocortine (Melanocortin receptor ligands) ⤷  Try a Trial
Denmark 3354273 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for setmelanotide acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2970389 C202130071 Spain ⤷  Try a Trial PRODUCT NAME: IMCIVREE-SETMELANOTIDA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1564; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1564; DATE OF FIRST AUTHORISATION IN EEA: 20210716
2236151 C202130074 Spain ⤷  Try a Trial PRODUCT NAME: IMCIVREE-SETMELANOTIDA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1564; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1564; DATE OF FIRST AUTHORISATION IN EEA: 20210716
2970389 2190055-0 Sweden ⤷  Try a Trial PRODUCT NAME: SETMELANOTID; REG. NO/DATE: EU/1/21/1564 20210719
2970389 122021000083 Germany ⤷  Try a Trial PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 20210716
2236151 2021C/557 Belgium ⤷  Try a Trial PRODUCT NAME: SETMELANOTIDE, ALSMEDE DOOR HET BASISOCTROOI BESCHERMDE, THERAPEUTISCH EQUIVALENTE AFGELEIDEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1564 20210719
>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.