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-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
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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IMCIVREE
*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 |
Pharmacology for IMCIVREE
| Drug Class | Melanocortin 4 Receptor Agonist |
| Mechanism of Action | Melanocortin 4 Receptor Agonists |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Melanocortin receptor ligands
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Melanocortin receptor ligands
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH BARDET-BIEDL SYNDROME (BBS)
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Rhythm | IMCIVREE | setmelanotide acetate | SOLUTION;SUBCUTANEOUS | 213793-001 | Nov 25, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rhythm | IMCIVREE | setmelanotide acetate | SOLUTION;SUBCUTANEOUS | 213793-001 | Nov 25, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rhythm | IMCIVREE | setmelanotide acetate | SOLUTION;SUBCUTANEOUS | 213793-001 | Nov 25, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Rhythm | IMCIVREE | setmelanotide acetate | SOLUTION;SUBCUTANEOUS | 213793-001 | Nov 25, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Rhythm | IMCIVREE | setmelanotide acetate | SOLUTION;SUBCUTANEOUS | 213793-001 | Nov 25, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Patent: 19200101
Patent: Pharmaceutical Compositions
Estimated Expiration: ⤷ Sign Up
Patent: 21202699
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Patent: 23204625
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015023409
Patent: composições farmacêuticas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 06782
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 09602
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 5518021
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Patent: 5957296
Patent: 药物组合物 (Pharmaceutical composition)
Estimated Expiration: ⤷ Sign Up
Patent: 5957297
Patent: 药物组合物 (Pharmaceutical composition)
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 70389
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 70389
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 78623
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1059
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 20702
Patent: 藥物組合物 (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1378
Patent: תכשירים רוקחיים (Pharmaceutical compositions)
Estimated Expiration: ⤷ Sign Up
Patent: 8961
Patent: תכשירים רוקחיים (Pharmaceutical compositions)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 38025
Estimated Expiration: ⤷ Sign Up
Patent: 16516062
Patent: 医薬組成物
Estimated Expiration: ⤷ Sign Up
Patent: 19189619
Patent: 医薬組成物 (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 22065117
Patent: 医薬組成物
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1149
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 70389
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 70389
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 90377
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 15143965
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ
Estimated Expiration: ⤷ Sign Up
Patent: 19116003
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2378943
Estimated Expiration: ⤷ Sign Up
Patent: 160020405
Patent: 약학적 조성물 (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 25076
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Australia | 2021202699 | Pharmaceutical compositions | ⤷ Sign Up |
| Israel | 241378 | תכשירים רוקחיים (Pharmaceutical compositions) | ⤷ Sign Up |
| European Patent Office | 2286825 | Ligands des récépteurs de la mélanocortine (Melanocortin receptor ligands) | ⤷ Sign Up |
| European Patent Office | 2236151 | Ligands des récepteurs de la melanocortine (Melanocortin receptor ligands) | ⤷ Sign Up |
| Russian Federation | 2690377 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| Canada | 2906782 | COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IMCIVREE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2236151 | CA 2021 00053 | Denmark | ⤷ Sign Up | PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719 |
| 2970389 | 53/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 (MITTEILUNG) 20210719 |
| 2236151 | CR 2021 00053 | Denmark | ⤷ Sign Up | PRODUCT NAME: SETMELANOTID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1564 20210719 |
| 2236151 | 52/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: SETMELANOTID; REGISTRATION NO/DATE: EU/1/21/1564 (MITTEILUNG) 20210719 |
| 2970389 | C202130071 | Spain | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: SETMELANOTIDE, ALSMEDE DOOR HET BASISOCTROOI BESCHERMDE, THERAPEUTISCH EQUIVALENTE AFGELEIDEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1564 20210719 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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