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Last Updated: July 7, 2020

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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

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Summary for SCENESSE
International Patents:34
US Patents:2
Applicants:1
NDAs:1
DailyMed Link:SCENESSE at DailyMed
Drug patent expirations by year for SCENESSE
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.

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

Supplementary Protection Certificates for SCENESSE

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