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IMCIVREE Drug Patent Profile

When do Imcivree patents expire, and what generic alternatives are available?

Imcivree is a drug marketed by Rhythm and is included in one NDA. There are three patents protecting this drug.

This drug has ninety-four patent family members in twenty-one countries.

The generic ingredient in IMCIVREE is setmelanotide acetate. One supplier is listed for this compound. Additional details are available on the setmelanotide acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Imcivree

Imcivree will be eligible for patent challenges on November 25, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 4, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IMCIVREE

International Patents:	94
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	1
Drug Prices:	Drug price information for IMCIVREE
What excipients (inactive ingredients) are in IMCIVREE?	IMCIVREE excipients list
DailyMed Link:	IMCIVREE at DailyMed

See drug prices for IMCIVREE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for IMCIVREE

NDA:

213793

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.

Recent Clinical Trials for IMCIVREE

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

Sponsor	Phase
Rhythm Pharmaceuticals, Inc.	Phase 3

See all IMCIVREE clinical trials

Pharmacology for IMCIVREE

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

Anatomical Therapeutic Chemical (ATC) Classes for IMCIVREE

A08AA	Centrally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for IMCIVREE

IMCIVREE is protected by three US patents and four FDA Regulatory Exclusivities.

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 IMCIVREE

FDA Regulatory Exclusivity protecting IMCIVREE

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

International Patents for IMCIVREE

When does loss-of-exclusivity occur for IMCIVREE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

France

Hong Kong

Israel

Japan

Netherlands

Poland

Portugal

Russian Federation

South Korea

Spain

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 IMCIVREE around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	163585	MELANOCORTIN RECEPTOR LIGANDS
Denmark	2286825
Poland	3354273
Poland	2236151
Portugal	2286825
Japan	2009500427
Russian Federation	2690377	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for IMCIVREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2970389	53/2021	Austria		PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 (MITTEILUNG) 20210719
2236151	CA 2021 00053	Denmark		PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719
2970389	21C1059	France		PRODUCT NAME: SETMELANOTIDE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1564 20210719
2236151	301150	Netherlands		PRODUCT NAME: SETMELANOTIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/21/1564 20210719
2970389	C202130071	Spain		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	CA 2021 00054	Denmark		PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719
2970389	122021000083	Germany		PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 20210716