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Last Updated: May 22, 2022

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

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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
Drug patent expirations by year for SCENESSE
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

SponsorPhase
Clinuvel Europe LimitedPhase 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 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

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
McKesson
Boehringer Ingelheim
Moodys
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.