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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. One supplier is listed for this compound. Additional details are available on the afamelanotide profile page.

DrugPatentWatch^® Generic Entry Outlook for Scenesse

Scenesse was eligible for patent challenges on October 8, 2023.

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

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Summary for SCENESSE

International Patents:	34
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	3
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

Drug patent expirations by year for SCENESSE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SCENESSE

Generic Entry Date for SCENESSE^: ⤷ Subscribe* 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, Inc.	Phase 3
Clinuvel Europe Limited	Phase 2

See all SCENESSE clinical trials

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 ⤷ Subscribe.

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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Subscribe

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Glossary

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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	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for SCENESSE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for SCENESSE

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

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Country	Patent Number	Title	Estimated Expiration
New Zealand	582130	Methods of inducing melanogenesis in a subject	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2006012667		⤷ Subscribe
Japan	2008508324		⤷ Subscribe
European Patent Office	2865422	Dérivés de la MSH-Alpha pour le traitement de photodermatoses (Alpha-MSH derivatives for the treatment of photodermatoses)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SCENESSE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2865422	663	Finland	⤷ Subscribe
2865422	SPC/GB18/012	United Kingdom	⤷ Subscribe	PRODUCT NAME: AFAMELANOTIDE; REGISTERED: UK EU/1/14/969 (NI) 20141222; UK PLGB 30619/0002 20141222
2865422	132018000000241	Italy	⤷ Subscribe	PRODUCT NAME: AFAMELANOTIDE(SCENESSE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/969, 20141229
2865422	18C1014	France	⤷ Subscribe	PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU 1/14/969 20141229
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description