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IMCIVREE Drug Profile
» See Plans and Pricing
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 two patents protecting this drug.
This drug has fifty-two patent family members in seventeen countries.
The generic ingredient in IMCIVREE is setmelanotide acetate. Additional details are available on the setmelanotide acetate profile page.
US ANDA Litigation and 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 October 13, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for IMCIVREE
| International Patents: | 52 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| DailyMed Link: | IMCIVREE at DailyMed |
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.
US Patents and Regulatory Information for IMCIVREE
| 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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Rhythm | IMCIVREE | setmelanotide acetate | SOLUTION;SUBCUTANEOUS | 213793-001 | Nov 25, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Rhythm | IMCIVREE | setmelanotide acetate | SOLUTION;SUBCUTANEOUS | 213793-001 | Nov 25, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 2548568 | Start Trial |
| Hong Kong | 1149190 | Start Trial |
| European Patent Office | 2286825 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
