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Last Updated: May 26, 2022

IMCIVREE Drug Patent Profile


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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

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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
Drug patent expirations by year for IMCIVREE
DrugPatentWatch® Estimated Generic Entry Opportunity Date for IMCIVREE
Generic Entry Date for IMCIVREE*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for IMCIVREE

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IMCIVREE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Melanocortin receptor ligands
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Melanocortin receptor ligands
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting IMCIVREE

INDICATED FOR CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH OBESITY DUE TO PROOPIOMELANOCORTIN (POMC), PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 1 (PCSK1), OR LEPTIN RECEPTOR (LEPR) DEFICIENCY CONFIRMED BY GENETIC TESTING DEMONSTRATING VARIANTS IN POMC, PCSK1, OR LEPR GENES THAT ARE INTERPRETED AS PATHOGENIC, LIKELY PATHOGENIC, OR OF UNCERTAIN SIGNIFICANCE (VUS)
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: 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
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 Y 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 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

Patent: 14228460
Estimated Expiration: See Plans and Pricing

Patent: 19200101
Estimated Expiration: See Plans and Pricing

Patent: 21202699
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015023409
Estimated Expiration: See Plans and Pricing

Canada

Patent: 06782
Estimated Expiration: See Plans and Pricing

China

Patent: 5518021
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 70389
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 70389
Estimated Expiration: See Plans and Pricing

Patent: 78623
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 20702
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1378
Estimated Expiration: See Plans and Pricing

Patent: 8961
Estimated Expiration: See Plans and Pricing

Japan

Patent: 38025
Estimated Expiration: See Plans and Pricing

Patent: 16516062
Estimated Expiration: See Plans and Pricing

Patent: 19189619
Estimated Expiration: See Plans and Pricing

Poland

Patent: 70389
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 70389
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 90377
Estimated Expiration: See Plans and Pricing

Patent: 15143965
Estimated Expiration: See Plans and Pricing

Patent: 19116003
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2378943
Estimated Expiration: See Plans and Pricing

Patent: 160020405
Estimated Expiration: See Plans and Pricing

Spain

Patent: 25076
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
Israel 288961 See Plans and Pricing
Russian Federation 2015143965 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IMCIVREE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 CA 2021 00053 Denmark See Plans and Pricing PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Moodys
Medtronic
Johnson and Johnson
Express Scripts
Colorcon

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.