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
Slovenia	2056855
New Zealand	575133
Canada	2662163
Cyprus	1115804

Supplementary Protection Certificates for SCENESSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2865422	2018/008	Ireland		PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222
2865422	CA 2018 00014	Denmark		PRODUCT NAME: AFAMELANOTIDE SAMT FARMACEUTISK ACCEPTABLE SALTE ELLER HYDRATER HERAF; REG. NO/DATE: EU/1/14/969 20141229
2865422	2018C/012	Belgium		PRODUCT NAME: AFAMELANOTIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/969 20141229
2865422	SPC/GB18/012	United Kingdom		PRODUCT NAME: AFAMELANOTIDE; REGISTERED: UK EU/1/14/969 (NI) 20141222; UK PLGB 30619/0002 20141222

Market Dynamics and Financial Trajectory for SCENESSE (Afamelanotide)

Last updated: July 27, 2025

Introduction

SCENESSE (afamelanotide) is a pioneering pharmaceutical approved for the treatment of erythropoietic protoporphyria (EPP), a rare genetic disorder characterized by severe photosensitivity leading to painful skin reactions upon exposure to sunlight. Since its approval, SCENESSE's market dynamics have evolved amid rising demand for orphan drugs, expanding indications, and competitive landscape shifts. This article provides a comprehensive analysis of SCENESSE's market environment, key drivers, revenue projections, and strategic outlook.

Overview of SCENESSE and its Market Position

Mechanism of Action and Therapeutic Benefit
SCENESSE contains afamelanotide, a synthetic analog of alpha-melanocyte-stimulating hormone (α-MSH). It promotes increased melanin production, providing photoprotection in patients with EPP. Its innovative mechanism transforms EPP management by offering symptom relief and improving quality of life [1].

Regulatory Approvals and Geographic Footprint
Initially approved in the European Union in 2014, SCENESSE has secured approvals in multiple regions, including the United States (FDA approval in 2019) and other markets. Its orphan drug designation has facilitated expedited development and market exclusivity, bolstering its commercial position [2].

Market Penetration and Adoption
While EPP affects approximately 1 in 1 million individuals worldwide, patient identification and diagnosis remain challenging, impacting overall treatment uptake. Nonetheless, adoption among specialized centers has increased, driven by physician awareness and advocacy.

Market Drivers

1. Growing Global Awareness of Rare Diseases

The global push for orphan drug development, supported by policies like the Orphan Drug Act (USA) and similar regulations in Europe, incentivizes pharmaceutical innovation targeting rare diseases like EPP [3].

2. Incremental Expansion of Indications

Research exploring SCENESSE’s utility in other photosensitive conditions, such as vitiligo and certain dermatological disorders, could expand its market potential. Although no additional indications have yet received approval, ongoing clinical studies suggest future growth pathways.

3. Enhanced Disease Diagnosis and Patient Identification

Advancements in genetic testing and increased physician awareness lead to earlier diagnoses, increasing available patient populations for SCENESSE treatment.

4. Pricing and Reimbursement Policies

High treatment costs (approximately $14,000–$20,000 per dose in the U.S.) are offset by reimbursement mechanisms, though pricing pressures and policy reforms could influence revenue streams.

5. Competitive Landscape and Alternative Therapies

Currently, no approved pharmacologic alternatives exist for EPP. Symptom management remains supportive, giving SCENESSE a near-monopoly in its niche. However, emerging gene therapies and innovative treatments could pose future threats.

Market Challenges

1. Limited Patient Population

EPP’s rarity constrains revenue potential. Commercial success hinges on effective patient identification and market penetration efforts.

2. Pricing and Access Barriers

High treatment costs could limit access in lower-income regions and under certain healthcare systems, impacting global market share.

3. Clinical and Regulatory Risks

Ongoing trials for new indications and post-marketing surveillance might uncover safety concerns or hinder approval processes.

4. Manufacturing and Supply Constraints

Ensuring consistent, high-quality production of afamelanotide for global demand poses supply chain risks, especially amidst regulatory scrutiny.

Financial Trajectory Analysis

Revenue Trends and Forecasts

Since its launch, SCENESSE has demonstrated steady revenue growth in its core markets. In 2021, branded sales eclipsed $100 million, reflecting increased adoption and expanding reimbursement coverage across Europe and the U.S. [4].

Market analysts project compounded annual growth rates (CAGRs) of approximately 10-12% over the next five years, driven by the following factors:

• Market Penetration in the U.S.: Reimbursement approval and physician adoption are predicted to propel sales toward $200 million by 2027.
• European Market Expansion: With more regions recognizing its efficacy, revenue could approach $150 million, supported by broader access initiatives.
• Potential New Indications: If clinical trials validate additional uses, an uplift in revenues is anticipated, potentially adding $50–$100 million annually.

Cost Structures and Profit Margins

The high cost of goods sold (COGS), manufacturing complexities, and targeted marketing efforts imply gross margins of around 60–70%. Operating expenses, including R&D, regulatory compliance, and sales, account for roughly 30–40% of revenues.

Strategic Revenue Enhancements

• Market Expansion: Penetrating emerging markets, such as Asia-Pacific, could unlock additional revenue streams.
• Pricing Strategies: Value-based pricing and tiered reimbursement models might optimize profit margins.
• Partnerships: Collaborations with healthcare providers and patient advocacy groups can accelerate adoption.

Risks to Financial Forecast

• Pricing Pressures: Reimbursement reforms could compress prices.
• Market Saturation: Limited patient pool constrains long-term growth.
• Clinical Setbacks: Unforeseen safety or efficacy issues may delay growth.

Future Outlook and Strategic Considerations

Innovation and Pipeline Development
Active research initiatives focus on refining afamelanotide formulations and exploring new delivery mechanisms—such as implantable devices—to enhance patient compliance and reduce treatment frequency.

Regulatory and Policy Trends
Advocacy for broader coverage of orphan drugs and potential policy reforms in healthcare spending could influence profitability and market access strategies.

Competitive Positioning
While no direct competitors exist, technological advancements, such as gene editing or biomarker-guided therapies, could reshape the treatment landscape of photosensitivity disorders.

Partnerships and Licensing
Strategic alliances with biotech firms and academic institutions may expand clinical development and augment market reach.

Key Market Dynamics Summary

• Growth is driven primarily by increased awareness, regulatory incentives, and geographic expansion.
• Pricing policies and healthcare reimbursement frameworks will significantly influence revenue trajectory.
• Limited patient population remains a fundamental constraint, emphasizing targeted marketing and clinical outreach.
• Ongoing innovation offers potential for future revenue diversification, should new indications prove viable.

Conclusion

SCENESSE’s market landscape exhibits robust growth prospects, bolstered by orphan drug incentives and evolving treatment paradigms. However, its financial trajectory is tightly bound to clinical success, regulatory developments, and healthcare policy environments. Companies operating within this space must focus on precision targeting, comprehensive stakeholder engagement, and strategic pipeline expansion to sustain long-term profitability.

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Key Takeaways

• Market growth hinges on expanding awareness, geographic reach, and reimbursement access, with projected revenues hitting approximately $200 million by 2027 in established markets.
• Limited patient numbers impose significant revenue ceilings; thus, innovation and pipeline diversification are critical for future growth.
• Pricing strategies and healthcare policy reforms are potential revenue moderators, requiring proactive engagement with payers.
• Strategic partnerships with academic and biotech entities can bolster clinical development and market penetration.
• Monitoring emerging therapies and technological advances remains essential to maintain competitive advantage within this niche.

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FAQs

1. What factors contribute to the market growth of SCENESSE?
Market growth is driven by increased disease awareness, regulatory incentives for orphan drugs, expanded geographic approval, and ongoing research exploring additional indications.

2. How does the rarity of EPP impact SCENESSE’s revenue potential?
The small patient population limits absolute sales volume, making market penetration, reimbursement, and pricing strategies vital for financial sustainability.

3. Are there any upcoming competitors or alternative therapies for EPP?
Currently, no direct pharmacologic competitors exist; however, research into gene therapies and novel biomolecular approaches could introduce new treatment options in the future.

4. What are the main challenges facing SCENESSE’s commercial success?
Key challenges include limited patient numbers, high treatment costs affecting access, and regulatory or safety issues potentially delaying uptake.

5. What strategic actions can enhance SCENESSE’s long-term financial trajectory?
Expanding into emerging markets, pursuing additional indications, forming strategic alliances, and innovating delivery mechanisms can reinforce growth and profitability.

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References

[1] European Medicines Agency. "SCENESSE (afamelanotide): Summary of Product Characteristics," 2014.
[2] U.S. Food and Drug Administration. "FDA Approves New Treatment for Rare Disease," 2019.
[3] U.S. Department of Health and Human Services. "Orphan Drug Act," 1983.
[4] Company Financial Reports, 2021.