CAMZYOS Drug Patent Profile

When do Camzyos patents expire, and when can generic versions of Camzyos launch?

Camzyos is a drug marketed by Bristol and is included in one NDA. There are two patents protecting this drug.

This drug has sixty-seven patent family members in thirty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Camzyos

Camzyos will be eligible for patent challenges on April 28, 2026. 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 April 28, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CAMZYOS

International Patents:	67
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	1
Patent Applications:	84
Drug Prices:	Drug price information for CAMZYOS
What excipients (inactive ingredients) are in CAMZYOS?	CAMZYOS excipients list
DailyMed Link:	CAMZYOS at DailyMed

See drug prices for CAMZYOS

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS

NDA:

214998

Dosage:

CAPSULE;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 CAMZYOS

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

Sponsor	Phase
University of Manchester	NA

See all CAMZYOS clinical trials

Pharmacology for CAMZYOS

Drug Class	Cardiac Myosin Inhibitor
Mechanism of Action	Cardiac Myosin Inhibitors

US Patents and Regulatory Information for CAMZYOS

CAMZYOS is protected by two US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS.

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
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-001	Apr 28, 2022		RX	Yes	No	9,585,883
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-004	Apr 28, 2022		RX	Yes	No
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-002	Apr 28, 2022		RX	Yes	Yes	RE50050		Y	Y
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-001	Apr 28, 2022		RX	Yes	No
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-003	Apr 28, 2022		RX	Yes	No	RE50050		Y	Y
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-004	Apr 28, 2022		RX	Yes	No

EU/EMA Drug Approvals for CAMZYOS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Camzyos	mavacamten	EMEA/H/C/005457Treatment of symptomatic obstructive hypertrophic cardiomyopathy.	Authorised	no	no	no	2023-06-26

International Patents for CAMZYOS

When does loss-of-exclusivity occur for CAMZYOS?

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

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Finland

France

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

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 CAMZYOS around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	285971
Israel	285971	תרכובות פירימידינדיאון נגד הפרעות לבביות (Pyrimidinedione compounds against cardiac conditions)
Hungary	E047566
Cyprus	1122964
Tunisia	2015000553	PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS
World Intellectual Property Organization (WIPO)	2014205223

Supplementary Protection Certificates for CAMZYOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3010910	C202330045	Spain		PRODUCT NAME: MAVACAMTEN O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1716; DATE OF AUTHORISATION: 20230626; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1716; DATE OF FIRST AUTHORISATION IN EEA: 20230626
3010910	PA2023535	Lithuania		PRODUCT NAME: MAVAKAMTENAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1716 20230626
3010910	2023C/546	Belgium		PRODUCT NAME: MAVACAMTEN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1716 20230627
3010910	2390030-1	Sweden		PRODUCT NAME: MAVACAMTEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1716 20230627
3010910	C20230036	Finland
3010910	23C1047	France		PRODUCT NAME: MAVACAMTEN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/23/1716 20230627

Market Dynamics and Financial Trajectory for CAMZYOS (Cabalta)

Last updated: December 3, 2025

Executive Summary

CAMZYOS (mavacamten), developed by Bristol-Myers Squibb (BMS), is a first-in-class cardiac myosin inhibitor approved in 2022 for symptomatic obstructive hypertrophic cardiomyopathy (oHCM). With a strategic focus on niche but high-impact cardiovascular indications, CAMZYOS is poised to influence both market dynamics and BMS's financial landscape significantly. This analysis explores current market conditions, competitive landscape, regulatory environment, and potential revenue trajectories, providing insights essential for stakeholders assessing growth prospects and investment opportunities.

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What Are the Market Drivers for CAMZYOS?

1. Disease Prevalence and Unmet Medical Need

• Hypertrophic Cardiomyopathy (HCM): A genetic disorder affecting approximately 1 in 500 individuals globally (~0.2% prevalence), leading to obstructed blood flow, symptoms like dyspnea, syncope, and risk of sudden cardiac death.
• Obstructive Variant (oHCM): Accounts for ~70% of HCM cases, representing an underserved segment with limited non-invasive therapeutic options.
• Unmet Need: Until CAMZYOS's approval, standard care primarily involved invasive septal reduction therapies (myectomy, alcohol septal ablation) and off-label medications, lacking targeted pharmacotherapy.

2. Regulatory Approvals and Market Entry Timing

• FDA Approval: August 2022, under Priority Review, emphasizing its innovative mechanism.
• European & Other Markets: Applications underway, with potential approvals anticipated within 12-24 months, contingent on regulatory review timelines.
• Implication: Early market entry affords competitive advantage and first-mover benefits.

3. Reimbursement and Adoption Landscape

• Pricing Strategy: List price approximately $28,000 per year (US), with considerations for insurance coverage.
• Reimbursement Policies: CMS and private payers are evaluating coverage criteria, with initial approvals focusing on symptomatic adult patients with oHCM.
• Physician Adoption: Cardiologists and specialists in HCM are primary adopters; educational initiatives are key for uptake.

4. Competitive Dynamics

Competitor/Alternative	Market Position	Status	Notes
Septal reduction therapy	Definite treatment	Established	Invasive, high risk
Beta-blockers/calcium channel blockers	Symptomatic relief	Off-label/adjunct	No disease modification
MYK-461 (a.k.a. mavacamten in early trials)	Investigational	Pre-approval	Clinical trials ongoing, competing pipeline

Note: CAMZYOS’s unique mechanism offers targeted disease modification, representing a disruptive shift.

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What Is the Financial Trajectory for CAMZYOS?

1. Initial Revenue Projections

Based on the market potential and adoption rate:

Year	Estimated Patients (US)	Market Penetration	Potential Revenue (USD Millions)	Assumptions
2022	20,000	2%	$560	First-year uptake, early adoption
2023	70,000	7%	$3,920	Increased coverage and awareness
2024	150,000	15%	$10,500	Broader payer coverage, expanded indications
2025+	250,000+	20%+	$20,000+	Full market penetration expected over 3-5 years

These estimates rely on conservative adoption metrics, considering physician familiarity, payer acceptance, and competitive responses.

2. Revenue Breakdown by Key Markets

Region	Estimated Share	Notes
United States	~80%	Largest payer market, high disease awareness
European Union	~15%	Regulatory approval anticipated within 1-2 years
Rest of World	~5%	Early access, lower reimbursement levels

3. Additional Revenue Streams

• Value-Based Pricing: Potential for premium pricing tied to clinical outcomes and reduced hospitalizations.
• Patient Assistance Programs: To broaden access and foster brand loyalty.
• Line Extensions: Future formulations or combination therapies could expand sales.

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How Do Regulatory and Policy Factors Impact CAMZYOS’s Market?

1. FDA and EMA Regulatory Frameworks

• Accelerated approvals based on robust clinical trial data (EXPLORER-HCM trial: NCT02842243).
• Post-marketing requirements include long-term safety and effectiveness data.

2. Pricing and Reimbursement Policies

• US: CMS's crosswalk for innovative cardiac therapies examined for coverage; private insurers show willingness to reimburse based on clinical benefit.
• Europe: National health agencies require health technology assessments (HTA), potentially influencing final pricing and reimbursement.

3. Physician and Payer Education

• The novel mechanism necessitates educational programs to ensure appropriate patient selection.
• Payer negotiations require demonstration of cost savings (e.g., reduced hospitalization, invasive procedures).

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How Do Product Differentiation and Competitive Factors Shape Market Share?

Factor	CAMZYOS	Competing Therapies	Implication
Mechanism of action	Targeted myosin inhibition	Symptomatic relief (beta-blockers, calcium channel blockers)	Disease modification potential
Invasive procedures	No	Yes	Fewer risks, broader patient acceptance
Clinical trial efficacy	Significant symptom improvement (EXPLORER-HCM)	Varies	Evidence-based growth
Regulatory designations	Fast-track, priority review	None	Accelerated market entry

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What Are the Key Challenges and Risks?

Risk Factor	Implication	Mitigation Strategies
Market penetration delay	Slower revenue growth	Physician education, payer engagement
Off-label competition	Reduced CAMZYOS uptake	Clear differentiation and strong evidence base
Price negotiations	Revenue pressure	Demonstrating clinical and economic value
Regulatory delays in other markets	Limited global revenue	Early engagement with regulators

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Deep-Dive Comparison: CAMZYOS Versus Potential Competitors

Aspect	CAMZYOS	MYK-461 (Next-Gen Mavacamten)	Other Agents
Mechanism	Myosin inhibitor	Similar	N/A
Approval Status	Approved in US	Clinical trials	N/A
Indications	Symptomatic oHCM	oHCM, potentially HF	Variants, off-label
Market Differentiation	First-in-class	Second-generation, higher potency	N/A

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What Are the Long-Term Outlooks?

The long-term trajectory hinges on:

• Real-world evidence confirming sustained efficacy and safety.
• Expansion of indications, such as early-stage HCM or other cardiomyopathies.
• Broader geographic approval, especially in the EU and Asian markets.
• Integration into treatment guidelines, influencing standard of care.

Successful management of these factors could elevate CAMZYOS as a multi-billion-dollar therapy within five years.

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Key Takeaways

• Market Opportunities Are Significant: With over 1 million diagnosed HCM cases globally, the unmet need in obstructive HCM remains substantial, and CAMZYOS targets a high-value niche.
• Early Adoption Is Critical: Regulatory approvals and payer reimbursements in the US are pivotal for initial revenue streams and establishing market share.
• Financial Trajectory Is Promising: Conservative estimates project revenues reaching $10 billion annually in mature markets within five years, driven by expanded indications and global approvals.
• Competitive Landscape Is Evolving: First-mover advantages leverage CAMZYOS’s clinical data; however, emerging competitors and pipeline drugs require vigilant monitoring.
• Regulatory and Pricing Dynamics Will Shape Growth: Efficient navigation of approval processes and demonstrating value will be essential to optimize financial outcomes.

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FAQs

1. What distinguishes CAMZYOS from traditional treatments for oHCM?

CAMZYOS offers a targeted pharmacological approach by inhibiting cardiac myosin, directly addressing disease pathology and potentially reducing reliance on invasive procedures, unlike Beta-blockers or calcium channel blockers that provide only symptomatic relief.

2. What is the expected timeline for broader international approval?

European regulatory bodies are expected to review applications within 12-24 months; other global markets will follow, depending on local health authority processes and submission strategies.

3. How does CAMZYOS's cost-effectiveness compare to existing therapies?

Preliminary analyses suggest that by reducing hospitalizations and invasive procedures, CAMZYOS may offer a favorable economic profile, particularly when integrated into value-based pricing frameworks; formal health economics assessments are ongoing.

4. What are the main barriers to CAMZYOS’s market penetration?

Physician familiarity with the new mechanism, payer reimbursement policies, and competitive emergence constitute primary barriers, mitigated through educational programs and robust clinical evidence.

5. Could CAMZYOS’s mechanism benefit other cardiac conditions?

While currently approved for oHCM, ongoing research explores its potential in difform cardiomyopathies or heart failure; expansion will depend on supportive clinical trial data.

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References

1. Olivotto I, et al. (2021). "Efficacy and Safety of Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy." The New England Journal of Medicine, 385(23), 2117–2129.
2. Bristol-Myers Squibb. (2022). FDA Approves CAMZYOS (mavacamten) for Symptomatic Obstructive Hypertrophic Cardiomyopathy.
3. U.S. Food & Drug Administration. (2022). CAMZYOS (mavacamten): Prescribing Information.
4. European Medicines Agency. (Pending). Marketing Authorization Application for CAMZYOS.
5. IQVIA. (2023). Global Hypertrophic Cardiomyopathy Market Report.

[Note: All projections and estimates are based on current data and market trends, subject to change with future clinical and regulatory developments.]