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Last Updated: February 16, 2025

SCENESSE Drug Patent Profile


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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

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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: 1
Drug Prices: Drug price information for SCENESSE
What excipients (inactive ingredients) are in SCENESSE?SCENESSE excipients list
DailyMed Link:SCENESSE at DailyMed
Drug patent expirations by year for SCENESSE
Drug Prices for SCENESSE

See drug prices for SCENESSE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SCENESSE
Generic Entry 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:
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

SponsorPhase
Clinuvel, Inc.Phase 3
Clinuvel Europe LimitedPhase 2

See all SCENESSE clinical trials

US Patents and Regulatory Information for SCENESSE

SCENESSE is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SCENESSE is ⤷  Try for Free.

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 ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>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 SCENESSE

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

International Patents for SCENESSE

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2006012667 ⤷  Try for Free
Denmark 1789076 ⤷  Try for Free
Japan 2008508324 ⤷  Try for Free
Slovenia 1789076 ⤷  Try for Free
Poland 2056855 ⤷  Try for Free
Spain 2646049 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SCENESSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2865422 SPC/GB18/012 United Kingdom ⤷  Try for Free PRODUCT NAME: AFAMELANOTIDE; REGISTERED: UK EU/1/14/969 (NI) 20141222; UK PLGB 30619/0002 20141222
2865422 1890011-8 Sweden ⤷  Try for Free PRODUCT NAME: AFAMELANOTIDE; REG. NO/DATE: EU/1/14/969 20141229
2865422 LUC00062 Luxembourg ⤷  Try for Free PRODUCT NAME: AFAMELANOTIDE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (SCENESSE); AUTHORISATION NUMBER AND DATE: EU/1/14/969 20141229
2865422 132018000000241 Italy ⤷  Try for Free PRODUCT NAME: AFAMELANOTIDE(SCENESSE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/969, 20141229
2865422 405 8-2018 Slovakia ⤷  Try for Free PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 20141229
2865422 663 Finland ⤷  Try for Free
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for SCENESSE

Introduction

SCENESSE®, developed by CLINUVEL Pharmaceuticals, is a groundbreaking drug designed to treat erythropoietic protoporphyria (EPP), a rare genetic disorder characterized by an intense sensitivity to light. This article delves into the market dynamics and financial trajectory of SCENESSE, highlighting its impact, growth, and future prospects.

Regulatory Approval and Market Entry

SCENESSE® received regulatory approval from the European Medicines Agency (EMA) in 2015, marking a significant milestone in its journey to market[5].

  • This approval was a result of collaborative efforts between CLINUVEL and Evonik, which developed the controlled release system for the drug.
  • The commercial phase of SCENESSE® began in June 2016, following European marketing authorization.

Clinical Demand and Revenue Growth

The demand for SCENESSE® has been a driving force behind CLINUVEL's financial success.

  • For the six months ending December 2022, CLINUVEL reported a 19% increase in revenues, primarily driven by the clinical demand for SCENESSE®[1][3].
  • This increase reflects the growing need for effective treatments for EPP patients and the expanding reach of the drug in European and US markets.

Financial Performance

CLINUVEL's financial performance has been robust, with several key indicators highlighting its success.

  • Revenue Increase: A 19% rise in revenues to $29.36 million for the half year ending December 2022[1][3].
  • Net Profit: A 94% increase in net profit after tax to $11.39 million, marking the highest December half-year profit recorded by the company[1][3].
  • Earnings Per Share: Basic earnings per share increased by 93% to $0.230[1][3].

Profitability and Cash Reserves

The company's profitability has been consistent, with several consecutive years of growth.

  • Consecutive Profits: CLINUVEL has recorded fourteen consecutive half-year profits since the commencement of its commercial operations in June 2016[1].
  • Cash Reserves: The company's cash reserves have grown significantly, with a 16% increase to $140.7 million as of December 2022[1][3].

Balance Sheet and Fiscal Discipline

CLINUVEL's financial management has been prudent, ensuring a strong balance sheet.

  • Expense Control: The company contained its expenses during the half year period, achieving a negligible rise of 1%[1].
  • Total Assets: Total assets have increased, with net assets up by 11% and cash reserves at an all-time high[1].

Expansion and Diversification

The financial success of SCENESSE® has provided CLINUVEL with the resources to expand and diversify its operations.

  • Market Expansion: The company is focused on expanding its market reach and diversifying its product portfolio, including advancing its melanocortin research and developing new pharmaceutical products[1][2].
  • Long-term Objectives: CLINUVEL aims to become an integrated, diversified, and sustainable pharmaceutical group, with a clear trajectory outlined for the financial years ending June 2025 and beyond[2].

Research and Development

CLINUVEL's commitment to research and development is crucial for its long-term success.

  • Clinical Programs: The company continues to invest in clinical research and new product development, ensuring a pipeline of innovative treatments[2].
  • Cost Control: Despite these investments, CLINUVEL maintains a focus on cost control, balancing expansion with fiscal discipline[1].

ESG Practices and Sustainability

CLINUVEL's approach to Environmental, Social, and Governance (ESG) practices is integral to its sustainability.

  • Sustainable Operations: The company emphasizes sustainable practices, ensuring that its operations are environmentally responsible and socially ethical[2].

Challenges and Risks

While SCENESSE® has seen significant success, there are challenges and risks associated with its development and market presence.

  • Supply Chain Risks: The COVID-19 pandemic and other external factors can impact the supply chain, affecting the development, manufacture, and distribution of SCENESSE®[4].
  • Regulatory Scrutiny: CLINUVEL faces increased government scrutiny in various regions, including Australia, the U.S., Europe, China, and Japan, which can affect its agreements with third parties and suppliers[4].

Patient Impact

The impact of SCENESSE® on patients with EPP is profound.

  • Symptom Relief: The drug provides relief from symptoms for up to two months, allowing patients to lead relatively normal lives despite their condition[5].
  • Quality of Life: By protecting the skin from bright visible light and UV radiation, SCENESSE® significantly improves the quality of life for EPP patients.

Industry Partnerships

The collaboration between CLINUVEL and Evonik has been instrumental in the development and manufacturing of SCENESSE®.

  • Technological Expertise: Evonik's expertise in formulating and developing complex, injectable drug products has been crucial in bringing SCENESSE® to market[5].

Future Prospects

CLINUVEL's future looks promising, with several key initiatives and goals outlined.

  • Market Diversification: The company aims to expand into new markets and diversify its product portfolio, ensuring long-term sustainability[2].
  • Financial Stability: With robust cash reserves and a strong balance sheet, CLINUVEL is well-positioned to pursue its long-term objectives[1][2].

Key Takeaways

  • Revenue Growth: SCENESSE® has driven a 19% increase in CLINUVEL's revenues.
  • Profitability: The company has seen a 94% increase in net profit after tax.
  • Cash Reserves: CLINUVEL's cash reserves have grown to $140.7 million.
  • Expansion: The company is focused on market expansion and product diversification.
  • Patient Impact: SCENESSE® significantly improves the quality of life for EPP patients.

FAQs

What is SCENESSE® used for?

SCENESSE® is used to treat erythropoietic protoporphyria (EPP), a rare genetic disorder characterized by an intense sensitivity to light.

Who developed SCENESSE®?

SCENESSE® was developed by CLINUVEL Pharmaceuticals, with significant contributions from Evonik in the development of the controlled release system.

What is the financial impact of SCENESSE® on CLINUVEL?

The demand for SCENESSE® has driven a 19% increase in revenues and a 94% increase in net profit after tax for CLINUVEL.

How does SCENESSE® improve the quality of life for EPP patients?

SCENESSE® protects the skin from bright visible light and UV radiation, allowing EPP patients to lead relatively normal lives despite their condition.

What are the future prospects for CLINUVEL and SCENESSE®?

CLINUVEL aims to expand into new markets, diversify its product portfolio, and continue advancing its research and development initiatives, ensuring long-term sustainability.

Sources

  1. Global SCENESSE® demand drives increased CLINUVEL revenues, earnings. GlobeNewswire, 2023.
  2. CLINUVEL Pharmaceuticals Ltd - For personal use only. ASX, 2023.
  3. CLINUVEL Pharmaceuticals Ltd S/ADR - CLVLY Stock News. StockTitan, 2023.
  4. CLINUVEL: 15 YEARS OF FOCUSED STRATEGY. Aspect Huntley, 2020.
  5. European approval for SCENESSE®, an extended-release pharmaceutical product developed and manufactured by CLINUVEL. Evonik, 2015.

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