IMCIVREE Drug Patent Profile
✉ Email this page to a colleague
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
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.
Anatomical Therapeutic Chemical (ATC) Classes for IMCIVREE
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 |