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AMONDYS 45 Drug Patent Profile

When do Amondys 45 patents expire, and what generic alternatives are available?

Amondys 45 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in AMONDYS 45 is casimersen. One supplier is listed for this compound. Additional details are available on the casimersen profile page.

DrugPatentWatch^® Generic Entry Outlook for Amondys 45

Amondys 45 will be eligible for patent challenges on February 25, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 12, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AMONDYS 45

International Patents:	87
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in AMONDYS 45?	AMONDYS 45 excipients list
DailyMed Link:	AMONDYS 45 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AMONDYS 45

NDA:

213026

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.

Pharmacology for AMONDYS 45

Drug Class	Antisense Oligonucleotide
Physiological Effect	Increased Protein Synthesis

US Patents and Regulatory Information for AMONDYS 45

AMONDYS 45 is protected by eight US patents and two FDA Regulatory Exclusivities.

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
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			Y	Y
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 AMONDYS 45

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 AMONDYS 45

When does loss-of-exclusivity occur for AMONDYS 45?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

New Zealand

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Turkey

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

See the table below for additional patents covering AMONDYS 45 around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1668028
European Patent Office	3228711	OLIGONUCLÉOTIDES ANTISENS PERMETTANT D'INDUIRE UN SAUT D'EXON ET LEURS PROCÉDÉS D'UTILISATION (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF)
Japan	2011172597	SPLICE-REGION ANTISENSE COMPOSITION AND METHOD
Spain	2361325
Denmark	2499249
Croatia	P20110352
Australia	2007297861

AMONDYS 45 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AMONDYS 45

Introduction to AMONDYS 45

AMONDYS 45, developed by Sarepta Therapeutics, is a phosphorodiamidate morpholino oligomer (PMO) therapy designed to treat Duchenne muscular dystrophy (DMD) by skipping exon 45 of the dystrophin gene. This drug, along with EXONDYS 51 and VYONDYS 53, represents a significant advancement in the treatment of DMD, a rare and debilitating genetic disorder.

FDA Approval and Clinical Significance

AMONDYS 45 received accelerated approval from the U.S. Food and Drug Administration (FDA) on February 25, 2021. The approval was based on clinical trials that showed the drug could increase dystrophin levels in patients from less than 1% to about 2% after treatment[1][3].

Market Impact

The approval of AMONDYS 45 has expanded the treatment options for DMD patients, with the drug now addressing mutations amenable to exon 45 skipping. This addition means that there are now medicines available to treat approximately 30% of DMD patients, according to data from CureDuchenne[1].

Financial Performance

Revenue Growth

The introduction of AMONDYS 45 has contributed significantly to Sarepta's revenue growth. For the first quarter of 2023, Sarepta reported total revenues of $253.5 million, with net product revenues increasing by $42.7 million compared to the same period in 2022. This growth is largely attributed to the increasing demand for the company's PMO therapies, including AMONDYS 45[2].

In the fourth quarter of 2023, Sarepta's net product revenue grew by 55% compared to the same quarter in 2022, with full-year net product revenue reaching $1.14 billion, a 36% increase from 2022. This robust growth underscores the market acceptance and financial impact of AMONDYS 45 and other PMO therapies[4].

Analyst Projections

Analysts have been optimistic about the financial potential of AMONDYS 45. For instance, Piper Sandler analyst Tyler Van Buren projected that the drug could generate approximately $300 million in sales by 2025[1].

Competitive Landscape

The approval of AMONDYS 45 occurs in a competitive landscape where other treatments for DMD are emerging. The August 2020 approval of Viltepso, a competing drug from NS Pharma, introduced the first direct competition to Sarepta's PMO therapies. Additionally, gene therapy programs from other companies, including Pfizer, are advancing, which could impact the market dynamics in the future[1].

Financial Challenges and Setbacks

Despite the positive revenue growth, Sarepta has faced financial challenges. The company reported a net loss of $516.8 million for the first quarter of 2023, primarily due to a loss on debt extinguishment. On a non-GAAP basis, the net loss was $85.5 million. These financial results highlight the ongoing operational costs and investment in research and development that Sarepta incurs[2].

A significant setback for Sarepta was the failure of its high-profile gene therapy program to significantly improve motor function in DMD patients. This news led to a more than 50% drop in Sarepta's stock price, erasing about $6.5 billion from the company's market value[1].

Cash and Investment Position

As of March 31, 2023, Sarepta had approximately $1.9 billion in cash, cash equivalents, investments, and long-term restricted cash. This financial cushion is crucial for funding the company's ongoing operations and research initiatives[2].

Recent Developments and Outlook

In the third quarter of 2024, Sarepta continued to see strong performance from its PMO therapies, including AMONDYS 45, with net product revenue reaching approximately $248.8 million. The company's total revenues for the quarter were $467.2 million, reflecting a 41% increase from the same period in 2023[5].

The successful launch of Sarepta's gene therapy, ELEVIDYS, alongside the continued growth of its PMO therapies, positions the company for further expansion in the DMD treatment market.

Key Takeaways

• Expanded Treatment Options: AMONDYS 45 has increased the number of DMD patients who can be treated, addressing mutations amenable to exon 45 skipping.
• Revenue Growth: The drug has significantly contributed to Sarepta's revenue growth, with total revenues increasing by 41% in the third quarter of 2024.
• Competitive Landscape: The market is becoming more competitive with the introduction of other DMD treatments, including gene therapies.
• Financial Challenges: Despite revenue growth, Sarepta faces financial challenges, including significant net losses and high operational costs.
• Strong Financial Position: The company maintains a substantial cash and investment position to support ongoing operations and research.

FAQs

Q: What is AMONDYS 45 used for? A: AMONDYS 45 is used to treat Duchenne muscular dystrophy (DMD) by skipping exon 45 of the dystrophin gene.

Q: When was AMONDYS 45 approved by the FDA? A: AMONDYS 45 was approved by the FDA on February 25, 2021.

Q: How does AMONDYS 45 impact Sarepta's revenue? A: AMONDYS 45 has contributed significantly to Sarepta's revenue growth, with the company reporting increased net product revenues in recent quarters.

Q: What are the financial projections for AMONDYS 45? A: Analysts project that AMONDYS 45 could generate approximately $300 million in sales by 2025.

Q: What challenges does Sarepta face in the DMD treatment market? A: Sarepta faces competition from other DMD treatments, including gene therapies, and has experienced financial setbacks due to high operational costs and research failures.

Sources

1. Biopharma Dive: "Sarepta wins FDA approval of another drug for rare muscular dystrophy"
2. Business Wire: "Sarepta Therapeutics Announces First Quarter 2023 Financial Results and Recent Corporate Developments"
3. Sarepta Therapeutics Investor Relations: "SAREPTA THERAPEUTICS, INC."
4. Sarepta Therapeutics Investor Relations: "Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results"
5. Sarepta Therapeutics Investor Relations: "Sarepta Therapeutics Announces Third Quarter 2024 Financial Results"