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Last Updated: November 30, 2023

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 ninety-two 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

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Summary for IMCIVREE
International Patents:92
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
Drug patent expirations by year for IMCIVREE
Drug Prices for IMCIVREE

See drug prices for IMCIVREE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for IMCIVREE

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

SponsorPhase
Rhythm Pharmaceuticals, Inc.Phase 3

See all IMCIVREE clinical trials

Pharmacology for IMCIVREE

US Patents and Regulatory Information for IMCIVREE

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IMCIVREE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Melanocortin receptor ligands
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Melanocortin receptor ligands
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

FOR CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH MONOGENIC OR SYNDROMIC OBESITY DUE TO BARDET-BIEDL SYNDROME (BBS)
Exclusivity Expiration: ⤷  Try a Trial

CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH BARDET-BIEDL SYNDROME (BBS)
Exclusivity Expiration: ⤷  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
Rhythm IMCIVREE setmelanotide acetate SOLUTION;SUBCUTANEOUS 213793-001 Nov 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial 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 ⤷  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
>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: ⤷  Try a Trial

Patent: 19200101
Estimated Expiration: ⤷  Try a Trial

Patent: 21202699
Estimated Expiration: ⤷  Try a Trial

Patent: 23204625
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015023409
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 06782
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5518021
Estimated Expiration: ⤷  Try a Trial

Patent: 5957296
Estimated Expiration: ⤷  Try a Trial

Patent: 5957297
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 70389
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 70389
Estimated Expiration: ⤷  Try a Trial

Patent: 78623
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1059
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 20702
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1378
Estimated Expiration: ⤷  Try a Trial

Patent: 8961
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 38025
Estimated Expiration: ⤷  Try a Trial

Patent: 16516062
Estimated Expiration: ⤷  Try a Trial

Patent: 19189619
Estimated Expiration: ⤷  Try a Trial

Patent: 22065117
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 1149
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 70389
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 70389
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 90377
Estimated Expiration: ⤷  Try a Trial

Patent: 15143965
Estimated Expiration: ⤷  Try a Trial

Patent: 19116003
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2378943
Estimated Expiration: ⤷  Try a Trial

Patent: 160020405
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 25076
Estimated Expiration: ⤷  Try a Trial

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
European Patent Office 2970389 COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
Israel 188545 MELANOCORTIN RECEPTOR AGONIST COMPOUND, PHARMACEUTICAL COMPOSITION COMPRISING SUCH A COMPOUND AND USE THEREOF IN THE MANUFACTURE OF MEDICAMENTS FOR TREATING DISORDERS ⤷  Try a Trial
Japan 6538025 ⤷  Try a Trial
Japan 5965520 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IMCIVREE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236151 2190056-8 Sweden ⤷  Try a Trial PRODUCT NAME: SETMELANOTID; REG. NO/DATE: EU/1/21/1564 20210719
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
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
2970389 301149 Netherlands ⤷  Try a Trial PRODUCT NAME: SETMELANOTIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/21/1564 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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Colorcon

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