Setmelanotide acetate - Generic Drug Details
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What are the generic sources for setmelanotide acetate and what is the scope of freedom to operate?
Setmelanotide acetate
is the generic ingredient in one branded drug marketed by Rhythm and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Setmelanotide acetate has ninety-four patent family members in twenty-one countries.
One supplier is listed for this compound.
Summary for setmelanotide acetate
| International Patents: | 94 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 23 |
| Patent Applications: | 82 |
| DailyMed Link: | setmelanotide acetate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for setmelanotide acetate
*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.
Pharmacology for setmelanotide acetate
| Drug Class | Melanocortin 4 Receptor Agonist |
| Mechanism of Action | Melanocortin 4 Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for setmelanotide acetate
US Patents and Regulatory Information for setmelanotide acetate
| 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 | ⤷ 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 | ⤷ 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 | ||||
| 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 setmelanotide acetate
| 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 |
| Japan | 6538025 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for setmelanotide acetate
| 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 |
| 2236151 | 301150 | Netherlands | ⤷ Sign Up | 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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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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