CASIMERSEN - Generic Drug Details

What are the generic drug sources for casimersen and what is the scope of freedom to operate?

Casimersen is the generic ingredient in one branded drug marketed by Sarepta Theraps Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Casimersen has eighty-seven patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for CASIMERSEN

International Patents:	87
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
What excipients (inactive ingredients) are in CASIMERSEN?	CASIMERSEN excipients list
DailyMed Link:	CASIMERSEN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CASIMERSEN

Dosage:

SOLUTION;INTRAVENOUS

^*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 CASIMERSEN

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

Sponsor	Phase
Kevin Flanigan	Phase 2
Sarepta Therapeutics, Inc.	Phase 2
Sarepta Therapeutics	Phase 3

See all CASIMERSEN clinical trials

Pharmacology for CASIMERSEN

Drug Class	Antisense Oligonucleotide
Physiological Effect	Increased Protein Synthesis

Anatomical Therapeutic Chemical (ATC) Classes for CASIMERSEN

M09AX	Other drugs for disorders of the musculo-skeletal system
M09A	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M09	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M	Musculo-skeletal system

US Patents and Regulatory Information for CASIMERSEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes			Y	Y
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes			Y	Y
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes

Expired US Patents for CASIMERSEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021

International Patents for CASIMERSEN

Country	Patent Number	Title	Estimated Expiration
Spain	2627917
Denmark	2499249
Cyprus	1121198
Australia	2018202105	Antisense Molecules and Methods for Treating Pathologies

CASIMERSEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Casimersen

Introduction to Casimersen

Casimersen, developed by Sarepta Therapeutics, is an investigational drug designed for the treatment of Duchenne Muscular Dystrophy (DMD), a severe genetic disorder characterized by progressive muscle degeneration. Here, we delve into the market dynamics and financial trajectory of Casimersen.

Mechanism of Action and Clinical Development

Casimersen works through the mechanism of exon skipping, a technique that aims to skip specific exons in the dystrophin gene to restore the production of a functional dystrophin protein. This approach is crucial for patients with DMD who have specific genetic mutations that prevent normal dystrophin production[4].

The drug is currently in the phase II stage of clinical development, with ongoing trials assessing its safety, efficacy, and optimal dosage. The clinical trials cover various interventions, trial conditions, and statuses, providing comprehensive data on its potential as a treatment for DMD[1][4].

Market Assessment

The global market for DMD drugs is projected to experience significant growth, driven by extensive research and increasing healthcare spending. Here are some key market assessments:

Global Market Size

The global DMD drugs market is estimated to reach $18.1 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 42.5% from 2022 to 2030. The exon skipping segment, which includes Casimersen, is expected to record a CAGR of 48.6% and reach $12.8 billion by the end of the analysis period[3].

Regional Market Analysis

• United States: The U.S. market for DMD drugs was estimated at $312.7 million in 2022 and is expected to grow significantly.
• Europe: Countries like Germany, France, Italy, Spain, and the UK (EU5) are forecasted to grow at varying CAGRs, with Germany expected to grow at approximately 28.5% CAGR.
• Japan: The Japanese market is forecasted to grow at 39.3% CAGR from 2022 to 2030[3][4].

Financial Trajectory

Forecasted Sales

The report on Casimersen provides forecasted sales data from 2020 to 2030. The drug's market size in the seven major markets (the United States, EU5, and Japan) is expected to increase substantially over this period. Historical and forecasted sales data indicate a promising financial trajectory for Casimersen, supporting decision-making processes for therapeutic portfolios[1][4].

Revenue Growth

Sarepta Therapeutics, the developer of Casimersen, has seen significant revenue growth. For example, in the second quarter of 2024, Sarepta's net product revenues totaled $360.5 million, a 51% increase over the same quarter of the prior year. This growth is indicative of the potential financial success of Casimersen and other DMD treatments[2].

Competitive Landscape

The market for DMD drugs is competitive, with several other approved products and late-stage emerging therapies. Casimersen faces competition from other exon skipping therapies and steroid therapies. However, its unique mechanism of action and the ongoing research to improve its efficacy position it as a significant player in the market[1][3][4].

Regulatory Milestones and Development Activities

Casimersen has achieved several regulatory milestones, including key designations that support its development. The drug's development activities are closely monitored, with detailed descriptions of regulatory milestones, clinical trials, and other development activities provided in comprehensive reports[1][4].

SWOT Analysis

A SWOT analysis of Casimersen highlights its strengths, such as its novel approach to treating DMD through exon skipping, and its weaknesses, including the competitive market landscape. Opportunities include the growing demand for DMD treatments and the potential for expansion into new markets. Threats include the emergence of new therapies and regulatory challenges[1][4].

Late-Stage Emerging Therapies

The launch of late-stage emerging therapies in the near future will significantly impact the market for Casimersen. These therapies are focused on novel approaches to treat and improve DMD, which could either complement or compete with Casimersen. The report provides a comprehensive coverage of these emerging therapies, helping stakeholders understand the evolving market dynamics[1][4].

Patent Details and Expiry Timeline

The patent details of Casimersen, including the expiry timeline, are crucial for understanding its long-term market potential. The report provides insights into the patent landscape, which is essential for strategic planning and investment decisions[1][4].

Key Takeaways

• Growing Market: The global DMD drugs market is expected to grow significantly, reaching $18.1 billion by 2030.
• Regional Growth: The U.S., EU5, and Japan are key markets with high growth potential.
• Forecasted Sales: Casimersen's sales are forecasted to increase substantially from 2020 to 2030.
• Competitive Landscape: Casimersen faces competition from other DMD treatments but has a unique mechanism of action.
• Regulatory Milestones: The drug has achieved significant regulatory milestones.
• SWOT Analysis: Understanding the strengths, weaknesses, opportunities, and threats is crucial for strategic planning.

FAQs

1. What is Casimersen used for?

   • Casimersen is an investigational drug used for the treatment of Duchenne Muscular Dystrophy (DMD).

2. Who is developing Casimersen?

   • Casimersen is being developed by Sarepta Therapeutics.

3. What is the mechanism of action of Casimersen?

   • Casimersen works through the mechanism of exon skipping to restore the production of a functional dystrophin protein.

4. What is the projected market size for DMD drugs by 2030?

   • The global DMD drugs market is projected to reach $18.1 billion by 2030.

5. What are the key regions for Casimersen's market growth?

   • The key regions include the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan.

Cited Sources

1. ResearchAndMarkets.com - Casimersen - Drug Insight and Market Forecast - 2030
2. Sarepta Therapeutics - Sarepta Therapeutics Announces Second Quarter 2024 Financial Results
3. GlobeNewswire - Global Duchenne Muscular Dystrophy Drugs Market to Reach $18.1 Billion by 2030
4. BusinessWire - Casimersen (Sarepta Therapeutics) Drug Report 2020: Emerging Insights and Market Forecast to 2030