DrugPatentWatch Database Preview
SCENESSE Drug Profile
Email this page to a colleague
See Plans and PricingWhen do Scenesse patents expire, and what generic alternatives are available?
Scenesse is a drug marketed by Clivunel Inc and is included in one NDA. There are two patents protecting this drug.
This drug has thirty-four patent family members in eighteen countries.
The generic ingredient in SCENESSE is afamelanotide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the afamelanotide profile page.
US ANDA Litigation and Generic Entry Outlook for Scenesse
Scenesse will be eligible for patent challenges on October 8, 2023. 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 8, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for SCENESSE
| International Patents: | 34 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| DailyMed Link: | SCENESSE at DailyMed |
Generic Entry Opportunity Date for SCENESSE
Generic Entry Date for SCENESSE*:
Constraining patent/regulatory exclusivity:
INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) NDA:
Dosage:
IMPLANT;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 SCENESSE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | 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 SCENESSE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2008508324 | Start Trial |
| Canada | 2662163 | Start Trial |
| Luxembourg | C00062 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SCENESSE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2865422 | 132018000000241 | Italy | Start Trial | PRODUCT NAME: AFAMELANOTIDE(SCENESSE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/969, 20141229 |
| 2865422 | 18C1014 | France | Start Trial | PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU 1/14/969 20141229 |
| 2865422 | CR 2018 00014 | Denmark | Start Trial | PRODUCT NAME: AFAMELANOTID; REG. NO/DATE: EU/1/14/969 20141229 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
