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SCENESSE Drug 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.

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
DailyMed Link:	SCENESSE at DailyMed

Generic Entry Opportunity 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:

210797

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
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes

International Patents for SCENESSE

Country	Patent Number	Estimated Expiration
South Africa	200901364
Slovenia	1789076
Canada	2662163
Denmark	2865422
Hong Kong	1130208
Australia	2005269244
Denmark	1789076

Supplementary Protection Certificates for SCENESSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2865422	300926	Netherlands		PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222
2865422	1890011-8	Sweden		PRODUCT NAME: AFAMELANOTIDE; REG. NO/DATE: EU/1/14/969 20141229
2865422	CA 2018 00014	Denmark		PRODUCT NAME: AFAMELANOTIDE SAMT FARMACEUTISK ACCEPTABLE SALTE ELLER HYDRATER HERAF; REG. NO/DATE: EU/1/14/969 20141229
2865422	CR 2018 00014	Denmark		PRODUCT NAME: AFAMELANOTID; REG. NO/DATE: EU/1/14/969 20141229
2865422	132018000000241	Italy		PRODUCT NAME: AFAMELANOTIDE(SCENESSE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/969, 20141229
2865422	18C1014	France		PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU 1/14/969 20141229
2865422	C201830012	Spain		PRODUCT NAME: AFAMELANOTIDA; NATIONAL AUTHORISATION NUMBER: EU/1/14/969; DATE OF AUTHORISATION: 20141222; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/969; DATE OF FIRST AUTHORISATION IN EEA: 20141222