Aficamten - Generic Drug Details

What are the generic sources for aficamten and what is the scope of patent protection?

Aficamten is the generic ingredient in one branded drug marketed by Cytokinetics and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aficamten has seventy-three patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for aficamten

International Patents:	73
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
Patent Applications:	46
What excipients (inactive ingredients) are in aficamten?	aficamten excipients list
DailyMed Link:	aficamten at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*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 aficamten

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

Sponsor	Phase
Bayer	PHASE3
Cytokinetics	PHASE2
Cytokinetics	Phase 1

See all aficamten clinical trials

US Patents and Regulatory Information for aficamten

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cytokinetics	MYQORZO	aficamten	TABLET;ORAL	219083-002	Dec 19, 2025		RX	Yes	No			Y	Y
Cytokinetics	MYQORZO	aficamten	TABLET;ORAL	219083-004	Dec 19, 2025		RX	Yes	No
Cytokinetics	MYQORZO	aficamten	TABLET;ORAL	219083-001	Dec 19, 2025		RX	Yes	Yes
Cytokinetics	MYQORZO	aficamten	TABLET;ORAL	219083-003	Dec 19, 2025		RX	Yes	No
Cytokinetics	MYQORZO	aficamten	TABLET;ORAL	219083-004	Dec 19, 2025		RX	Yes	No			Y	Y
Cytokinetics	MYQORZO	aficamten	TABLET;ORAL	219083-002	Dec 19, 2025		RX	Yes	No

International Patents for aficamten

Country	Patent Number	Title	Estimated Expiration
Singapore	11202006296Y
Australia	2024204859
Taiwan	202436291
Lithuania	3740481
Portugal	4370116
Lithuania	4370116

Market Dynamics and Financial Trajectory for Aficamten

Last updated: February 8, 2026

Aficamten, developed by Cytokinetics, is a myosin inhibitor targeted at treating hypertrophic cardiomyopathy (HCM). Since its clinical development, the drug has attracted investor interest due to its potential to address a significant unmet medical need.

Market Size and Opportunity

The global hypertrophic cardiomyopathy market was valued at approximately $1.7 billion in 2022 and is projected to reach over $3 billion by 2030, growing at a compound annual growth rate (CAGR) of around 7% (source: Frost & Sullivan).[1] The increasing prevalence of HCM, estimated at 1 in 500 individuals, paired with limited existing therapies, underscores a large unmet need.

Regulatory Status and Development Milestones

Cytokinetics completed a Phase 2 clinical trial (REDWOOD-HCM, NCT03812534) demonstrating favorable effects on left ventricular outflow tract obstruction and symptom relief. The data support continued development, with plans for Phase 3 trials expected to initiate in late 2023 or early 2024. The company is also exploring regulatory pathways for accelerated approval, especially in the U.S., where the FDA has shown receptiveness to novel therapies for rare diseases.

Competitive Landscape

Multiple companies pursue treatments for HCM, primarily focusing on symptom management and surgical interventions, including septal myectomy and alcohol septal ablation. Myosin inhibitors like aficamten are among the few targeted therapies in late-stage development. Cardior Pharmaceuticals’ mavacamten, another myosin inhibitor, achieved FDA approval in 2022 for obstructive HCM, setting a precedent that accelerates the market potential for similar drugs.[2]

Financial Trajectory and Investment Analysis

Cytokinetics secured approximately $220 million in revenue for 2022, primarily driven by collaborations with Amgen and internal pipeline products. The company's cash position stood at about $200 million at the end of Q4 2022. The ongoing advancement of aficamten involves costs ranging from $50 million to $100 million in the next 12-24 months, covering clinical trials, regulatory submissions, and commercialization preparations.

Analysts project that if aficamten gains approval, peak sales could surpass $1 billion annually worldwide. Implementing a direct-to-market approach could yield gross margins in the 70% range, typical for specialty pharmaceuticals with patent protection.

Market Entry Timeline and Commercial Strategy

Assuming successful late-stage trial results and FDA approval by 2025, marketing efforts will focus on cardiologists and rare disease specialists. Pricing strategies likely align with mavacamten’s treatment cost, estimated at approximately $300,000 annually, which impacts reimbursement and payer negotiations.

Intellectual Property and Competition

Cytokinetics holds patents protecting aficamten until at least 2035, with potential extensions. Competitive pressure from mavacamten and other emerging therapies may influence market share distribution. Licensing deals or partnerships with larger pharma companies could accelerate commercialization and distribution.

Risk Factors

• Clinical trial outcomes: Failure in Phase 3 would negate commercialization prospects.
• Regulatory hurdles: Any safety concerns could delay or restrict approval.
• Market penetration: Limited awareness or reimbursement barriers may slow sales.
• Competitive responses: Mavacamten's market presence could limit aficamten's uptake.

Summary of Financial forecast

Year	Milestones	Estimated R&D & Commercialization Cost	Potential Revenue	Market Penetration
2023	Initiation of Phase 3 trials	$50-80 million	None	Minimal
2024	Data readouts, regulatory filing	$50-80 million	None	Low
2025	Potential FDA approval	$50 million	Up to $200 million (early sales)	Growing
2026+	Market expansion, sales growth	$50-100 million post-launch	$500 million–$1 billion	Rapid growth

Key Takeaways

• Aficamten addresses a sizable and growing niche market for HCM therapeutics.
• The development pathway aligns with that of mavacamten, indicating favorable regulatory prospects.
• Financial success hinges on clinical outcomes, approval timing, and market penetration strategies.
• Competitive pressure from mavacamten may influence market share and pricing.

FAQs

1. What conditions does aficamten target?
   Hypertrophic cardiomyopathy, specifically obstructive forms involving left ventricular outflow tract obstruction.

2. How does aficamten differ from mavacamten?
   Both are myosin inhibitors, but aficamten's clinical data and enzyme selectivity are distinct. Development and regulatory timelines may vary due to differing trial outcomes.

3. When could aficamten reach the market?
   Potential FDA approval could occur by 2025, contingent on successful late-stage trial results.

4. What is the expected pricing model?
   Similar to mavacamten, likely around $300,000 annually, subject to insurance reimbursement and health system negotiations.

5. What are major risks for investors?
   Clinical trial failures, regulatory delays, competitive pressures, and market access challenges.

Sources

1. Frost & Sullivan. "Hypertrophic Cardiomyopathy Market Report," 2022.
2. FDA. "Mavacamten (Camzyos) Approval," 2022.