SCENESSE Drug Patent Profile

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. One supplier is listed 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	2
Patent Applications:	1
Drug Prices:	Drug price information for SCENESSE
What excipients (inactive ingredients) are in SCENESSE?	SCENESSE excipients list
DailyMed Link:	SCENESSE at DailyMed

See drug prices for SCENESSE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for SCENESSE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Clinuvel Europe Limited	Phase 2

See all SCENESSE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SCENESSE

D02BB	Protectives against UV-radiation for systemic use
D02B	PROTECTIVES AGAINST UV-RADIATION
D02	EMOLLIENTS AND PROTECTIVES
D	Dermatologicals

US Patents and Regulatory Information for SCENESSE

SCENESSE is protected by two US patents and two FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting 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

EU/EMA Drug Approvals for SCENESSE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Clinuvel Europe Limited	Scenesse	afamelanotide	EMEA/H/C/002548 Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).	Authorised	no	no	yes	2014-12-22

International Patents for SCENESSE

See the table below for patents covering SCENESSE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2007291886	Method of treatment of photodermatoses
World Intellectual Property Organization (WIPO)	2008025094
Spain	2566801
Canada	2575866	PROCEDES D'INDUCTION DE MELANOGENESE CHEZ UN SUJET (METHODS FOR INDUCING MELANOGENESIS IN A SUBJECT)
Slovenia	2865422
Slovenia	2056855
Hong Kong	1130208	用於治療光照性皮膚病的α- 衍生物 (ALPHA-MSH DERIVATIVES FOR THE TREATMENT OF PHOTODERMATOSES -MSH)

Supplementary Protection Certificates for SCENESSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2865422	2018/008	Ireland		PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222
2865422	CA 2018 00014	Denmark		PRODUCT NAME: AFAMELANOTIDE SAMT FARMACEUTISK ACCEPTABLE SALTE ELLER HYDRATER HERAF; REG. NO/DATE: EU/1/14/969 20141229
2865422	300926	Netherlands		PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222
2865422	18C1014	France		PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU 1/14/969 20141229
2865422	12/2018	Austria		PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 (MITTEILUNG) 20141229
2865422	2018C/012	Belgium		PRODUCT NAME: AFAMELANOTIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/969 20141229
2865422	1890011-8	Sweden		PRODUCT NAME: AFAMELANOTIDE; REG. NO/DATE: EU/1/14/969 20141229