SCENESSE Drug Patent Profile
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Which patents cover Scenesse, and when can generic versions of Scenesse launch?
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. Additional details are available on the afamelanotide profile page.
DrugPatentWatch® 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 |
Clinical Trials: | 1 |
What excipients (inactive ingredients) are in SCENESSE? | SCENESSE excipients list |
DailyMed Link: | SCENESSE at DailyMed |

DrugPatentWatch® Estimated 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.
Recent Clinical Trials for SCENESSE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Clinuvel Europe Limited | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for SCENESSE
US Patents and Regulatory Information for SCENESSE
SCENESSE is protected by two US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SCENESSE is See Plans and Pricing.
This potential generic entry date is based on INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP).
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SCENESSE
Methods of inducing melanogenesis in a subject
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
Method of treatment of photodermatoses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
FDA Regulatory Exclusivity protecting SCENESSE
INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
Exclusivity Expiration: See Plans and Pricing
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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
See the table below for patents covering SCENESSE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5208504 | See Plans and Pricing | |
China | 101076314 | Methods of inducing melanogenesis in a subject | See Plans and Pricing |
Slovenia | 1789076 | See Plans and Pricing | |
Canada | 2662163 | METHODE DE TRAITEMENT DE PHOTODERMATOSES (METHOD OF TREATMENT OF PHOTODERMATOSES) | See Plans and Pricing |
Hungary | E035074 | See Plans and Pricing | |
World Intellectual Property Organization (WIPO) | 2006012667 | See Plans and Pricing | |
European Patent Office | 2056855 | DÉRIVÉS DE LA MSH-ALPHA POUR LE TRAITEMENT DE PHOTODERMATOSES (ALPHA-MSH DERIVATIVES FOR THE TREATMENT OF PHOTODERMATOSES) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SCENESSE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2865422 | CR 2018 00014 | Denmark | See Plans and Pricing | PRODUCT NAME: AFAMELANOTID; REG. NO/DATE: EU/1/14/969 20141229 |
2865422 | 122018000148 | Germany | See Plans and Pricing | PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 20141222 |
2865422 | 12/2018 | Austria | See Plans and Pricing | PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 (MITTEILUNG) 20141229 |
2865422 | 405 8-2018 | Slovakia | See Plans and Pricing | PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 20141229 |
2865422 | 2018/008 | Ireland | See Plans and Pricing | PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222 |
2865422 | 18C1014 | France | See Plans and Pricing | PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU 1/14/969 20141229 |
2865422 | 300926 | Netherlands | See Plans and Pricing | PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |