SCENESSE Drug Patent Profile

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. One supplier is listed for this compound. Additional details are available on the afamelanotide profile page.

DrugPatentWatch^® Generic Entry Outlook for Scenesse

Scenesse was eligible for patent challenges on October 8, 2023.

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

Summary for SCENESSE

International Patents:	34
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	3
Patent Applications:	2
Drug Prices:	Drug price information for SCENESSE
What excipients (inactive ingredients) are in SCENESSE?	SCENESSE excipients list
DailyMed Link:	SCENESSE at DailyMed

See drug prices for SCENESSE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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:

210797

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 SCENESSE

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

Sponsor	Phase
Clinuvel, Inc.	Phase 3
Clinuvel Europe Limited	Phase 2

See all SCENESSE clinical trials

US Patents and Regulatory Information for SCENESSE

SCENESSE is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	10,076,555
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019		RX	Yes	Yes

Expired US Patents for SCENESSE

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 SCENESSE

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 SCENESSE

See the table below for patents covering SCENESSE around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E035074
European Patent Office	2865422
Slovenia	1789076

Supplementary Protection Certificates for SCENESSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2865422	405 8-2018	Slovakia		PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 20141229
2865422	CA 2018 00014	Denmark		PRODUCT NAME: AFAMELANOTIDE SAMT FARMACEUTISK ACCEPTABLE SALTE ELLER HYDRATER HERAF; REG. NO/DATE: EU/1/14/969 20141229
2865422	12/2018	Austria		PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 (MITTEILUNG) 20141229

Market Dynamics and Financial Trajectory for SCENESSE (afamelanotide)

Last updated: December 27, 2025

Executive Summary

SCENESSE (afamelanotide), developed by Clinuvel Pharmaceuticals, is a melanocortin-based drug primarily approved for the treatment of erythropoietic protoporphyria (EPP), a rare genetic disorder causing severe photosensitivity. Since its regulatory approval, SCENESSE has experienced steady market penetration, driven by increasing awareness of EPP, regulatory expansions, and strategic partnerships. The global orphan drug market, valued at approximately US$178 billion in 2022, underpins SCENESSE's niche focus, with projections indicating significant growth. This analysis explores the market environment, competitive landscape, financial outlook, and strategic factors shaping SCENESSE's trajectory.

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Market Overview and Dynamics

Global Market for Rare Disease Therapies

Aspect	Data Point	Sources/Notes
Global orphan drug market size (2022)	US$178 billion	[1]
CAGR (2023–2028)	~8%	[2]
Key drivers	Increased prevalence awareness, regulatory incentives, unmet medical needs	-

The orphan drug market's growth reflects rising demand for targeted therapies for rare conditions like EPP. Heightened regulatory support (e.g., FDA's Orphan Drug Designation, EMA's orphan status) incentivizes development and commercialization.

Erythropoietic Protoporphyria (EPP) Market

Attribute	Details	Notes
Prevalence	Estimated 1 in 50,000–75,000 globally	[3]
Total diagnosed cases	Approx. 10,000–15,000 patients worldwide	-
Regional distribution	Highest in Europe and North America	-
Market unmet needs	Severe photosensitivity, limited existing treatments	-

Regulatory Status and Approvals

Regulatory Body	Approval Status	Date	Notes
FDA	Approved	August 2019	First FDA-approved drug for EPP
EMA	Approved	August 2014	Prior to FDA approval, initial European approval
Japan	Approved	December 2019	Market expansion in Asia

Pricing and Reimbursement

Region	Approximate Pricing	Reimbursement Dynamics	Notes
US	~$240,000 per treatment course (per year)	Insurance coverage varies	High cost, limited competition
Europe	Varies €150,000–€200,000	Generally reimbursed via national healthcare systems	Cost-effectiveness assessments ongoing
Japan	Similar to Europe	Reimbursement schemes similar to US/Europe

Competitive Landscape

Current Market Players

Company	Drug	Indication	Approval Status	Key Strengths
Clinuvel Pharmaceuticals	SCENESSE (afamelanotide)	EPP	Approved (FDA, EMA, others)	First-in-class; orphan drug status
Other emerging contenders	None directly, but experimental therapies in development for related skin conditions	—	—	-

Competitive Advantages of SCENESSE

• Regulatory Approval & Orphan Designation: Facilitates market exclusivity (FDA grants 7 years, EMA 10 years exclusivity).
• Unique Mechanism of Action: Melanocortin pathway modulation reduces photosensitivity, addressing unmet needs.
• Proven Safety Profile: Extensive clinical trials and post-market surveillance.

Potential Threats

• Emerging Gene Therapies: Investigational treatments targeting enzyme deficiencies at the genetic level.
• Alternative Symptom Management: Supportive therapies for light sensitivity.
• Pricing Pressure: Cost containment in healthcare systems could impact revenue.

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Financial Trajectory Analysis

Revenue Potential

Year	Estimated Revenue (US$ million)	Assumptions	Sources
2022	~$50 million	1,200 treated patients globally at ~$42,000/year	Clinuvel annual disclosures; market estimates
2023	~$70 million	1,600 patients, slight price increase	Projected growth rate (40%) from 2022
2024–2028	CAGR 15–20%	Expanding indications & geographic expansion	Market trend forecasts

Cost Structure & Margins

Item	Estimated % of Revenue	Notes
R&D	30–40%	Ongoing clinical trials and pipeline development
SG&A	20–25%	Marketing, sales, regulatory expenses
COGS	15–20%	Production costs for peptide synthesis

Profitability Outlook

• EBITDA Margins: Expected to improve from ~20% in early years to over 30% as commercialization scales.
• Cash Flow: Positive from 2023 onward with increasing sales; potential reinvestment in pipeline.

Investment & Licensing Opportunities

• Partnerships: Strategic alliances for distribution in Asia and emerging markets.
• Pipeline Expansion: Development of formulations for additional indications like vitiligo, skin pigmentation disorders.
• Funding: Use of capital markets for R&D funding, with equity and debt instruments.

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Strategic Factors Shaping Future Trajectory

Regulatory Expansions & Approvals

• Off-label indications: Regulatory bodies might evaluate expansion into related dermatological conditions.
• New formulations: Long-acting formulations could improve adherence and reduce costs.

Market Penetration & Access Strategies

• Physician Engagement: Educating dermatologists and hematologists.
• Patient Advocacy: Collaborations with EPP patient groups to improve diagnosis rates and treatment access.
• Pricing & Reimbursement Negotiations: Demonstrating cost-effectiveness to secure reimbursement.

Pipeline & Development Trends

Drug Candidate	Indication	Current Status	Target Launch	Notes
SCENESSE 2.0	Extended indications (e.g., vitiligo)	Phase 2 trials	2025–2026	Potential incremental revenue
Novel peptide formulations	Different delivery systems	R&D stage	2024+	Improve adherence

Market Risks and Challenges

• Regulatory delays or rejections for new indications.
• Pricing pressure under national healthcare reforms.
• Market awareness gaps hindering adoption.

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Comparison with Other Orphan Drugs

Attribute	SCENESSE	Vorinostat (cancer)	Eculizumab (PNH)	Nusinersen (Spinal Muscular Atrophy)
Indication	EPP	Cancer	PNH	SMA
Market Size	Small (~10k–15k global)	Large (~100k+)	Moderate (~8k)	Small (~7k)
Approval Year	2014 (EMA), 2019 (FDA)	2006 (EMA/FDA)	2007	2016
Annual Revenue	US$50–70 million	Becomes billion-dollar drug	Over US$2 billion	US$1+ billion

[Sources: 1, 2, 3]

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Key Takeaways

• Niche but Expanding: SCENESSE occupies a narrow but growing market segment with high unmet needs.
• Regulatory Leadership: Early approvals and orphan designation confer market exclusivity and validate clinical efficacy.
• Revenue Growth Prospects: Projected CAGR of 15–20% over the next five years, driven by geographic expansion and potential new indications.
• Competitive Landscape: Limited direct competition presently, but emerging therapies could challenge market positioning.
• Strategic Opportunities: Pipeline expansion, formulation improvements, and global partnerships are critical for long-term growth.
• Market Risks: Pricing pressures, regulatory hurdles, and competitive innovations pose ongoing challenges.

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5 FAQs

1. What is the primary medical indication for SCENESSE?

SCENESSE (afamelanotide) is approved for the palliative treatment of erythropoietic protoporphyria (EPP), a rare genetic disorder causing extreme photosensitivity.

2. How does SCENESSE generate revenue across regions?

Revenue primarily derives from the US, Europe, and Japan, where pricing varies from ~$150,000 to $240,000 annually per patient, based on regional reimbursement policies and healthcare system dynamics.

3. What are the growth drivers for SCENESSE?

Growth drivers include increasing diagnosis rates, geographic expansion, regulatory approvals in new markets, and development of new formulations or indications.

4. Are there upcoming competitors or alternatives to SCENESSE?

Currently, no direct competitors, but research into gene therapies and alternative symptomatic treatments for light sensitivity could impact future market share.

5. What are the key challenges for SCENESSE’s financial trajectory?

Challenges include pricing pressures, securing reimbursement, regulatory delays for new indications, and the potential advent of innovative therapies challenging its market exclusivity.

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Sources

1. EvaluatePharma, “Global Orphan Drug Market Size,” 2022.
2. IQVIA, “Orphan Drug Market Forecast,” 2022.
3. European Medicines Agency, “EPP-approved treatments,” 2014.
4. Clinuvel Pharmaceuticals Annual Reports, 2019–2022.
5. PubMed, “Erythropoietic Protoporphyria Prevalence,” 2020.

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This analysis equips pharmaceutical and investor stakeholders with a comprehensive understanding of SCENESSE's market potential, competitive positioning, and financial outlook, guiding strategic decision-making.