Generic Imcivree Availability
Last updated on Apr 10, 2025.
Imcivree is a brand name of setmelanotide, approved by the FDA in the following formulation(s):
IMCIVREE (setmelanotide acetate - solution;subcutaneous)
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Manufacturer: RHYTHM
Approval date: November 25, 2020
Strength(s): EQ 10MG BASE/ML (EQ 10MG BASE/ML) [RLD]
Is there a generic version of Imcivree available?
No. There is currently no therapeutically equivalent version of Imcivree available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Imcivree. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Pharmaceutical compositions
Patent 11,129,869
Issued: September 28, 2021
Inventor(s): Sharma Shubh & Van Der Ploeg Leonardus H. T. & Henderson Bart
Assignee(s): RHYTHM PHARMACEUTICALS, INC.The present invention relates to an ionic complex comprising a cationic polypeptide and an anionic excipient selected from: a PEG-carboxylic acid; a fatty acid having 10 or more carbon atoms; an anionic phospholipid; and a combination thereof. The invention also relates to a pharmaceutical composition comprising the ionic complex of the invention and a pharmaceutically acceptable carrier. The cationic polypeptide of the ionic complex has pharmacological activity and the complex can provide a more desirable pharmacokinetic profile for the cationic polypeptide of the complex as compared to the cationic polypeptide alone following administration. As such, the invention also relates to the use of the ionic complex and pharmaceutical composition comprising same to treat a subject suffering from a disease or disorder that is responsive to the cationic polypeptide of the ionic complex.
Patent expiration dates:
- July 4, 2034✓
- July 4, 2034
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Melanocortin receptor ligands
Patent 8,039,435
Issued: October 18, 2011
Inventor(s): Dong; Zheng Xin et al.
Assignee(s): Ipsen Pharma S.A.S. (Boulogne, FR)The present invention is directed to compounds according to formula, (R.sup.2R.sup.3)-A.sup.1-c(A.sup.2-A.sup.3-A.sup.4-A.sup.5-A.sup.6-A.sup.- 7-A.sup.8-A.sup.9)-A.sup.10-R.sup.1, and pharmaceutically-acceptable salts thereof that act as ligands for one or more of the melanocortin receptors, to methods of using such compounds to treat mammals and to pharmaceutical compositions comprising said compounds.
Patent expiration dates:
- August 21, 2032✓✓
- August 21, 2032
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Melanocortin receptor ligands
Patent 9,458,195
Issued: October 4, 2016
Inventor(s): Dong Zheng Xin & Moreau Jacques-Pierre
Assignee(s): Ipsen Pharma S.A.S.The present invention is directed to compounds according to formula, (RR)-A-(A-A-A-A-A-A-A-A)-A-R, and pharmaceutically-acceptable salts thereof that act as ligands for one or more of the melanocortin receptors, to methods of using such compounds to treat mammals and to pharmaceutical compositions comprising said compounds.
Patent expiration dates:
- October 13, 2027✓✓
- October 13, 2027
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- June 16, 2025 - CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH BARDET-BIEDL SYNDROME (BBS)
- November 25, 2025 - NEW CHEMICAL ENTITY
- November 25, 2027 - 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 GENET
- December 20, 2027 - NEW PATIENT POPULATION
- June 16, 2029 - 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)
- December 20, 2031 - TO REDUCE EXCESS BODY WEIGHT AND MAINTAIN WEIGHT REDUCTION LONG TERM IN PEDIATRIC PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WITH SYNDROMIC OR MONOGENIC OBESITY DUE TO BARDET-BIEDL SYNDROME (BBS)
- December 20, 2031 - TO REDUCE EXCESS BODY WEIGHT AND MAINTAIN WEIGHT REDUCTION LONG TERM IN PEDIATRIC PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WITH SYNDROMIC OR MONOGENIC OBESITY DUE TO PRO-OPIOMELANOCORTIN (POMC), PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 1 (PCSK1), OR
More about Imcivree (setmelanotide)
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- During pregnancy
- FDA approval history
- Drug class: melanocortin receptor agonists
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
