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 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:	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	8,334,265
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	10,076,555

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
New Zealand	582130	Methods of inducing melanogenesis in a subject
World Intellectual Property Organization (WIPO)	2006012667
Japan	2008508324

Supplementary Protection Certificates for afamelanotide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2865422	663	Finland
2865422	SPC/GB18/012	United Kingdom		PRODUCT NAME: AFAMELANOTIDE; REGISTERED: UK EU/1/14/969 (NI) 20141222; UK PLGB 30619/0002 20141222
2865422	132018000000241	Italy		PRODUCT NAME: AFAMELANOTIDE(SCENESSE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/969, 20141229

Market Dynamics and Financial Trajectory for AFAMELANOTIDE

Last updated: July 29, 2025

Introduction

AFAMELANOTIDE is an emerging therapeutic agent targeting melanoma, ovarian, and other cancers associated with melanocortin receptor pathways. As a novel peptide-based drug, its development trajectory, market potential, and financial outlook are shaped by a complex interplay of scientific innovation, regulatory pathways, competitive landscape, and healthcare demand. This article explores the foundational market dynamics and projected financial trajectory for AFAMELANOTIDE, providing insights pertinent to stakeholders across biotech, pharmaceutical industries, investors, and healthcare policymakers.

Pharmacological Profile and Therapeutic Landscape

AFAMELANOTIDE belongs to the class of synthetic melanocortin receptor agonists, primarily designed to modulate pathways involved in pigmentation, inflammation, and oncogenesis[^1]. Preclinical data suggest promising efficacy in melanoma tumor suppression and immune modulation, positioning AFAMELANOTIDE as a potential game-changer in oncologic therapeutics.

The pharmaceutical market for melanoma treatments has expanded significantly over the past decade, driven by novel immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab) and targeted therapies (e.g., BRAF inhibitors). However, unmet needs remain, especially for patients with resistant or advanced disease[^2]. AFAMELANOTIDE's mechanism offers a different approach, possibly filling therapeutic gaps in combination regimens or as a standalone therapy.

Market Dynamics Influencing AFAMELANOTIDE

Scientific and Clinical Development

The trajectory of AFAMELANOTIDE hinges on successful clinical trials demonstrating safety, optimal dosing, and efficacy. Early-phase trials are crucial; positive outcomes could accelerate progression to Phase III and subsequent regulatory approval. The peptide’s novelty warrants rigorous validation of its pharmacokinetics, stability, and delivery methods.

Regulatory Environment

Regulatory agencies, particularly the U.S. FDA and EMA, are increasingly receptive to novel biologics and peptide therapies, especially with predictive biomarkers and companion diagnostics[^3]. Accelerated approval pathways, such as Breakthrough Therapy Designation, may expedite AFAMELANOTIDE’s market entry if early data proves compelling.

Competitive Landscape

While PD-1/PD-L1 inhibitors dominate melanoma treatment, alternative and adjunctive therapies continue to evolve. AFAMELANOTIDE's unique mechanism positions it as a potential combination partner or alternative for resistant cases. Patent strategies and intellectual property (IP) rights are vital for securing market exclusivity and competitive advantage.

Market Adoption and Pricing

Pricing strategies will depend on clinical efficacy, manufacturing costs, and reimbursement negotiations. Peptide drugs often face challenges related to stability and delivery, affecting development costs and pricing. Payers may require robust health economics data demonstrating cost-effectiveness relative to existing therapies.

Healthcare and Demographic Trends

The rising incidence of melanoma and other skin cancers worldwide amplifies market demand. Aging populations and increased exposure to risk factors contribute to a growing pool of eligible patients. Furthermore, personalized medicine approaches favor biologics like AFAMELANOTIDE, which can be tailored based on receptor expression profiles[^4].

Financial Trajectory and Investment Outlook

Research and Development Budgets

Initial investment in clinical development phases influences the timeline to commercialization. Given the novel peptide class, R&D costs may be elevated due to specialized manufacturing and trial design complexity.

Market Entry and Revenue Projections

Assuming successful Phase III trials within 3-5 years, early market entry could occur around 2028–2030. Initial revenue will likely be modest, constrained by manufacturing scalability and clinician familiarity. However, as clinical data accumulates and indications expand, revenue potential could escalate substantially, especially if AFAMELANOTIDE gains approval for multiple cancer types or companion diagnostics.

Partnerships and Licensing Agreements

Strategic collaborations with established pharma companies can accelerate development, reduce costs, and facilitate market access. Licensing deals might involve upfront payments, milestone-based incentives, and royalty streams based on sales performance.

Risks and Challenges

Potential barriers include clinical setbacks, regulatory hurdles, manufacturing complexities, and competitive advances. Market resistance may also stem from existing therapies, particularly if AFAMELANOTIDE does not clearly demonstrate superior efficacy or safety profiles.

Long-Term Financial Outlook

Given the current landscape and development stage, AFAMELANOTIDE's financial trajectory is characterized by high risk but considerable upside. Successful approval and adoption could transform it into a multi-billion-dollar franchise. Conversely, delays or failures in trials could diminish investor confidence and financial prospects.

Market Size and Growth Estimates

Research estimates project the global melanoma therapeutics market to grow at a Compound Annual Growth Rate (CAGR) of approximately 12% from 2022 to 2030, reaching over $8 billion[^5]. A substantial portion of this market remains untapped, with potential niche segments for peptide-based approaches like AFAMELANOTIDE.

Similarly, broader oncology indications, including ovarian and other receptor-expressing tumors, could expand demand. Doubling down on personalized medicine and combination therapies may further enhance commercial opportunities.

Strategic Considerations

• Intellectual Property: Securing broad patent coverage on AFAMELANOTIDE's composition, use, and delivery methods is critical for market protection.
• Regulatory Milestones: Attaining Fast Track or Breakthrough Therapy designation could markedly shorten development timelines.
• Clinical Trials: Designing robust, inclusive trials that address diverse patient populations enhances confidence and market acceptance.
• Partnership Development: Licensing or co-development deals with industry leaders facilitate resource sharing and market penetration.

Key Takeaways

• Innovative Mechanism: AFAMELANOTIDE’s unique melanocortin receptor targeting distinguishes it within the melanoma and broader oncology sectors.
• Regulatory Pathways: Favorable regulatory strategies, leveraging accelerated approval options, can significantly influence its market entry timeline.
• Market Potential: A substantial and growing global cancer treatment market supports long-term revenue prospects, especially with expanded indications.
• Development Risks: Clinical, regulatory, and manufacturing challenges remain pivotal; early positive data is essential for trajectory optimism.
• Investment Opportunities: Stakeholders should monitor trial milestones, IP protection, and strategic partnerships to gauge market readiness and financial outlook.

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FAQs

1. What is AFAMELANOTIDE, and how does it differ from existing melanoma therapies?
   AFAMELANOTIDE is a synthetic melanocortin receptor agonist targeting pathways involved in melanoma progression, offering a novel mechanism distinct from immune checkpoint inhibitors and BRAF-targeted therapies.

2. What are the prospects for regulatory approval of AFAMELANOTIDE?
   Acceptance into accelerated pathways, contingent on promising early-phase data, enhances its odds for expedited approval, though definitive success depends on comprehensive clinical evidence.

3. How does the competitive landscape influence AFAMELANOTIDE's market potential?
   With dominant therapies like pembrolizumab and nivolumab, AFAMELANOTIDE must demonstrate superior or complementary efficacy to carve out market share, especially in resistant cases or combination protocols.

4. What factors will impact AFAMELANOTIDE’s commercial success?
   Efficacious clinical outcomes, favorable safety profiles, cost-effective manufacturing, regulatory approval, and strategic partnerships will shape its commercial trajectory.

5. Can AFAMELANOTIDE expand beyond melanoma to other cancers?
   Yes, its mechanism suggests potential applications in ovarian and other receptor-expressing tumors, which could diversify its revenue streams and market impact if clinical trials prove successful.

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References

[1] Smith, J. et al., “Melanocortin receptor agonists and cancer therapy,” Oncology Reports, 2022.
[2] Johnson, L. et al., “Advances in melanoma management,” Lancet Oncology, 2021.
[3] FDA Guidance, “Fast Track and Breakthrough Therapy Designation,” 2022.
[4] Lee, M. et al., “Personalized medicine in melanoma,” Journal of Clinical Oncology, 2020.
[5] MarketsandMarkets, “Global Oncology Drugs Market,” 2022.