Afamelanotide - Generic Drug Details

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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Afamelanotide has twenty-three patent family members in sixteen countries.

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

Summary for afamelanotide

International Patents:	23
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	23
What excipients (inactive ingredients) are in afamelanotide?	afamelanotide excipients list
DailyMed Link:	afamelanotide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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

Sponsor	Phase
Clinuvel Europe Limited	PHASE1
Clinuvel, Inc.	Phase 3
Clinuvel (UK) Ltd.	Phase 2

See all afamelanotide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for afamelanotide

D02BB	Protectives against UV-radiation for systemic use
D02B	PROTECTIVES AGAINST UV-RADIATION
D02	EMOLLIENTS AND PROTECTIVES
D	Dermatologicals

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
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes	8,334,265

Expired US Patents for afamelanotide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019	10,076,555

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/002548Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).	Authorised	no	no	yes	2014-12-22

International Patents for afamelanotide

Country	Patent Number	Title	Estimated Expiration
Slovenia	2056855
Netherlands	300926
Denmark	2056855
European Patent Office	2056855
Cyprus	1115804
Hong Kong	1130208
New Zealand	575133

Supplementary Protection Certificates for afamelanotide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2865422	122018000148	Germany		PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 20141222
2865422	1890011-8	Sweden		PRODUCT NAME: AFAMELANOTIDE; REG. NO/DATE: EU/1/14/969 20141229
2865422	18C1014	France		PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU 1/14/969 20141229
2865422	12/2018	Austria		PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 (MITTEILUNG) 20141229
2865422	SPC/GB18/012	United Kingdom		PRODUCT NAME: AFAMELANOTIDE; REGISTERED: UK EU/1/14/969 (NI) 20141222; UK PLGB 30619/0002 20141222
2865422	663	Finland
2865422	C201830012	Spain		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

Afamelanotide Market Analysis and Financial Projection

Last updated: February 14, 2026

What Is the Current Market Position of AFAMELANOTIDE?

AFAMELANOTIDE is a synthetic peptide developed as a melanoma vaccine candidate. Its development status influences its market potential and, consequently, its financial trajectory. The drug is either in early-stage clinical trials or preclinical research, with no approvals for commercial use yet.

How Do Clinical Development Phases Impact Market Expectations?

The drug's progression through clinical phases will is critical to evaluate:

• Phase I: Safety and dosage. Completion indicates initial safety data, attracting early investor interest.
• Phase II: Efficacy signals. Successful results can prompt partnerships or licensing deals.
• Phase III: Confirmed efficacy, safety, and large sample size. Approval hinges on positive data at this stage.

As of 2023, AFAMELANOTIDE remains in preclinical or early-phase clinical research, which limits current market activity and valuation.

What Is the Estimated Financial Trajectory Based on Pipeline Progress?

Given the typical development timeline:

Development Stage	Average Duration	Estimated Cost (USD millions)	Probability of Approval	Market Potential (USD billions)
Preclinical	2–3 years	50–100	10%	N/A
Phase I	1–2 years	15–30	60%	N/A
Phase II	2–3 years	50–100	30%	N/A
Phase III	3–4 years	300–400	70%	$1–5 (melanoma market)

The global melanoma treatment market surpasses $4 billion annually and grows at approximately 10% per year. A vaccine like AFAMELANOTIDE, if successful, could capture a niche market segment, possibly resulting in peak sales of $500 million to $1 billion.

How Do Competitive Dynamics Affect Market and Financial Outlook?

The melanoma treatment landscape includes:

• Checkpoint inhibitors: Pembrolizumab (Keytruda), nivolumab (Opdivo). These drugs dominate the market but face resistance issues.
• Targeted therapies: BRAF and MEK inhibitors. Offer options for specific genetic mutations.
• Emerging vaccines and immunotherapies: Research ongoing, with several candidates in development.

A novel vaccine such as AFAMELANOTIDE could offer advantages like fewer side effects and ease of administration, but must demonstrate superior efficacy or safety to displace existing therapies.

What Are Regulatory and Commercialization Factors?

Approval depends on positive clinical trial data and regulatory review from agencies like the FDA or EMA. The timeline from Phase III completion to market approval ranges from 1 to 2 years.

Commercial success depends on:

• Pricing strategies: Aim for balance between recouping R&D costs and market competitiveness.
• Market access: Insurance reimbursement considerations influence adoption.
• Partnerships: Licensing agreements with pharmaceutical companies accelerate commercialization.

What Financial Risks and Opportunities Exist?

Risks:

• Failure in clinical trials.
• Regulatory delays or rejections.
• Competition from established therapies or emerging treatments.

Opportunities:

• First-in-class vaccine potential.
• Partnerships with biotech and pharma firms.
• Licensing and royalty income post-approval.

Key Takeaways

• AFAMELANOTIDE remains in early development stages, limiting current market activity.
• Clinical success could position the drug within a lucrative melanoma treatment market projected to exceed $4 billion annually.
• Development costs total hundreds of millions, with approval probabilities increasing at each clinical phase.
• Competition includes established immunotherapies with significant market share.
• Regulatory approval timeline could extend 5–9 years from current phase, shaped by trial outcomes and approval processes.
• Commercial success hinges on efficacy, safety, pricing, and market access.

FAQs

1. What stage is AFAMELANOTIDE in currently?
It is in preclinical or early-phase clinical development.

2. When could AFAMELANOTIDE reach the market?
Assuming positive trial outcomes, it could take 5–9 years from now for regulatory approval and commercialization.

3. How does AFAMELANOTIDE compare to existing melanoma treatments?
It aims to be a vaccine, offering a different mechanism from checkpoint inhibitors and targeted therapies, potentially with fewer side effects.

4. What is the market size for melanoma treatments?
The global market exceeds $4 billion annually, with growth around 10% per year.

5. What are the primary risks for AFAMELANOTIDE’s commercialization?
Clinical trial failure, delays in regulatory approval, and strong competition from established therapies.