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Last Updated: September 26, 2022

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.

Summary for afamelanotide
International Patents:34
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 14
Clinical Trials: 20
Patent Applications: 646
What excipients (inactive ingredients) are in afamelanotide?afamelanotide excipients list
DailyMed Link:afamelanotide at DailyMed
Recent Clinical Trials for afamelanotide

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

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

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 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

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

Supplementary Protection Certificates for afamelanotide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2865422 1890011-8 Sweden See Plans and Pricing PRODUCT NAME: AFAMELANOTIDE; REG. NO/DATE: EU/1/14/969 20141229
2865422 CR 2018 00014 Denmark See Plans and Pricing PRODUCT NAME: AFAMELANOTID; REG. 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Colorcon

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