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Last Updated: February 22, 2024

Afamelanotide - Generic Drug Details


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What are the generic sources for afamelanotide and what is the scope of patent protection?

Afamelanotide is the generic ingredient in one branded drug marketed by Clivunel Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Afamelanotide has thirty-four patent family members in eighteen countries.

There is one drug master file entry for afamelanotide. One supplier is listed for this compound.

Summary for afamelanotide
International Patents:34
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 26
Clinical Trials: 21
Patent Applications: 1,059
What excipients (inactive ingredients) are in afamelanotide?afamelanotide excipients list
DailyMed Link:afamelanotide at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for afamelanotide
Generic Entry Date for afamelanotide*:
Constraining patent/regulatory exclusivity:
INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
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 afamelanotide

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

SponsorPhase
Clinuvel (UK) Ltd.Phase 2
Clinuvel, Inc.Phase 2
Clinuvel (UK) Ltd.Phase 1

See all afamelanotide clinical trials

US Patents and Regulatory Information for afamelanotide

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 afamelanotide

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 afamelanotide

Country Patent Number Title Estimated Expiration
Hungary S1800006 ⤷  Try a Trial
Slovenia 2865422 ⤷  Try a Trial
Netherlands 300926 ⤷  Try a Trial
European Patent Office 2865422 Dérivés de la MSH-Alpha pour le traitement de photodermatoses (Alpha-MSH derivatives for the treatment of photodermatoses) ⤷  Try a Trial
Australia 2005269244 Methods of inducing melanogenesis in a subject. ⤷  Try a Trial
Spain 2646049 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for afamelanotide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2865422 2018C/012 Belgium ⤷  Try a Trial PRODUCT NAME: AFAMELANOTIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/969 20141229
2865422 300926 Netherlands ⤷  Try a Trial PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222
2865422 SPC/GB18/012 United Kingdom ⤷  Try a Trial PRODUCT NAME: AFAMELANOTIDE; REGISTERED: UK EU/1/14/969 (NI) 20141222; UK PLGB 30619/0002 20141222
2865422 18C1014 France ⤷  Try a Trial PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU 1/14/969 20141229
2865422 1890011-8 Sweden ⤷  Try a Trial PRODUCT NAME: AFAMELANOTIDE; REG. NO/DATE: EU/1/14/969 20141229
2865422 663 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.