Details for New Drug Application (NDA): 213793
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NDA 213793 describes IMCIVREE, which is a drug marketed by Rhythm and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the IMCIVREE profile page.
The generic ingredient in IMCIVREE is setmelanotide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the setmelanotide acetate profile page.
The generic ingredient in IMCIVREE is setmelanotide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the setmelanotide acetate profile page.
Summary for 213793
| Tradename: | IMCIVREE |
| Applicant: | Rhythm |
| Ingredient: | setmelanotide acetate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213793
Generic Entry Date for 213793*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 213793
| Mechanism of Action | Melanocortin 4 Receptor Agonists |
Suppliers and Packaging for NDA: 213793
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMCIVREE | setmelanotide acetate | SOLUTION;SUBCUTANEOUS | 213793 | NDA | Rhythm Pharmaceuticals, Inc | 72829-010 | 72829-010-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (72829-010-01) / 1 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 10MG BASE/ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Nov 25, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 16, 2029 | ||||||||
| Regulatory Exclusivity Use: | 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) | ||||||||
| Regulatory Exclusivity Expiration: | Nov 25, 2027 | ||||||||
| Regulatory Exclusivity Use: | 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) | ||||||||
| Regulatory Exclusivity Expiration: | Dec 20, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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