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 eighty-seven patent family members in twenty countries.

One supplier is listed for this compound.

Summary for setmelanotide acetate

International Patents:	87
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Patent Applications:	121
DailyMed Link:	setmelanotide acetate at DailyMed

Pharmacology for setmelanotide acetate

Drug Class	Melanocortin 4 Receptor Agonist
Mechanism of Action	Melanocortin 4 Receptor Agonists

US Patents and Regulatory Information for setmelanotide acetate

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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
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			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 setmelanotide acetate

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Country	Patent Number	Title	Estimated Expiration
Israel	288961	תכשירים רוקחיים (Pharmaceutical compositions)	See Plans and Pricing
Portugal	2286825		See Plans and Pricing
Singapore	163585	MELANOCORTIN RECEPTOR LIGANDS	See Plans and Pricing
Denmark	2236151		See Plans and Pricing
South Korea	20160020405	약학적 조성물 (PHARMACEUTICAL COMPOSITIONS)	See Plans and Pricing
Israel	241378	תכשירים רוקחיים (Pharmaceutical compositions)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for setmelanotide acetate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2970389	CA 2021 00054	Denmark	See Plans and Pricing	PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719
2236151	301150	Netherlands	See Plans and Pricing	PRODUCT NAME: SETMELANOTIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/21/1564 20210719
2236151	21C1060	France	See Plans and Pricing	PRODUCT NAME: SETMELANOTIDE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1564 20210719
2970389	2021C/551	Belgium	See Plans and Pricing	PRODUCT NAME: SETMELANOTIDE, ALSMEDE DOOR HET BASISOCTROOI BESCHERMDE, THERAPEUTISCH EQUIVALENTE AFGELEIDEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1564 20210719
2236151	52/2021	Austria	See Plans and Pricing	PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 (MITTEILUNG) 20210719
2236151	122021000084	Germany	See Plans and Pricing	PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 20210716
>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.