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 eighty-four patent family members in nineteen countries.

The generic ingredient in IMCIVREE is setmelanotide acetate. 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:	84
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	16
Patent Applications:	46
What excipients (inactive ingredients) are in IMCIVREE?	IMCIVREE excipients list
DailyMed Link:	IMCIVREE at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity 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.

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 two 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	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			Y	Y

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

Hong Kong

Israel

Japan

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
Russian Federation	2019116003	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ
Israel	288961
Russian Federation	2015143965	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ

Supplementary Protection Certificates for IMCIVREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2970389	2021C/551	Belgium		PRODUCT NAME: SETMELANOTIDE, ALSMEDE DOOR HET BASISOCTROOI BESCHERMDE, THERAPEUTISCH EQUIVALENTE AFGELEIDEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1564 20210719
2236151	CA 2021 00053	Denmark		PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719
2236151	52/2021	Austria		PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 (MITTEILUNG) 20210719