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
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			Y	Y
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-001	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

Luxembourg

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	323967
Denmark	3010910
China	105473576	Pyrimidinedione compounds against cardiac conditions
South Korea	20220020410

Supplementary Protection Certificates for CAMZYOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3010910	C03010910/01	Switzerland		PRODUCT NAME: MAVACAMTENUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68477 25.04.2023
3010910	CR 2023 00034	Denmark		PRODUCT NAME: MAVACAMTEN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1716 20230627
3010910	PA2023535,C3010910	Lithuania		PRODUCT NAME: MAVAKAMTENAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1716 20230626
3010910	23C1047	France		PRODUCT NAME: MAVACAMTEN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/23/1716 20230627

CAMZYOS (mavacamten) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

CAMZYOS (mavacamten), developed by Bristol Myers Squibb, is a first-in-class cardiac myosin inhibitor approved for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Its market trajectory is influenced by clinical efficacy, payer access, competitive landscape, and ongoing clinical development.

What is the current market penetration of CAMZYOS?

CAMZYOS received U.S. Food and Drug Administration (FDA) approval on February 28, 2022, for adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [1]. As of the first quarter of 2024, the drug has established a significant foothold in the oHCM market. Sales performance indicates increasing adoption among eligible patient populations.

In the first quarter of 2024, Bristol Myers Squibb reported $111 million in net sales for CAMZYOS [2]. This represents a substantial increase from the $77 million reported in the fourth quarter of 2023 and the $48 million in the third quarter of 2023 [3, 4]. Year-over-year growth for Q1 2024 was 130% [2]. This growth pattern suggests successful patient identification and treatment initiation by cardiologists specializing in HCM.

The prescription uptake has been tracked through various data sources. By the end of 2023, it was estimated that approximately 8,000 to 10,000 patients were on therapy across the U.S. [5]. New prescriptions (NRx) and total prescriptions (TRx) are key performance indicators monitored by the manufacturer and market analysts. For instance, in Q4 2023, it was noted that approximately 2,000 new patients initiated therapy with CAMZYOS [3].

What are the key drivers of CAMZYOS's commercial success?

The commercial success of CAMZYOS is driven by several factors:

• Novel Mechanism of Action: CAMZYOS is the first drug designed to directly target the underlying pathophysiology of HCM by reducing the excessive contractility of the cardiac myosin. This unique approach addresses a significant unmet medical need [6].
• Clinical Trial Data: Data from pivotal trials, such as the EXPLORER-HCM trial, demonstrated significant improvements in exercise capacity (VO2 max) and reduction in the outflow tract gradient (LVOT-G) in patients treated with mavacamten compared to placebo [7]. These robust clinical outcomes provide strong evidence for its efficacy.
• Physician Adoption: Cardiologists, particularly those in specialized HCM centers, are increasingly prescribing CAMZYOS. The drug's ability to improve symptoms and functional capacity, as evidenced in clinical trials, encourages its use in appropriate patients.
• Payer Access and Reimbursement: While initial market access can be challenging for novel therapies, sustained efforts by the manufacturer have resulted in broad payer coverage. This includes coverage by major commercial insurers and Medicare, facilitating patient access and reducing out-of-pocket costs. The drug is typically subject to prior authorization requirements, often necessitating confirmation of diagnosis and symptom severity [8].
• Patient Advocacy and Awareness: Growing awareness of HCM as a distinct condition and the availability of targeted therapies like CAMZYOS have empowered patients and advocacy groups. This can lead to increased diagnosis and demand for treatment options.
• Strategic Marketing and Sales Efforts: Bristol Myers Squibb has invested in a dedicated sales force and marketing campaigns to educate healthcare providers and patients about CAMZYOS and its benefits.

What is the competitive landscape for CAMZYOS?

The competitive landscape for CAMZYOS is evolving. Currently, it is the only FDA-approved medication that directly targets the underlying molecular mechanism of HCM. However, other therapeutic approaches are being developed or are already in use.

• Existing Therapies: Before CAMZYOS, treatment for symptomatic oHCM primarily involved medical management aimed at symptom relief. This included beta-blockers, calcium channel blockers, and disopyramide (often in combination with beta-blockers), which reduce heart rate and contractility but do not address the root cause [9]. Surgical interventions, such as septal myectomy and alcohol septal ablation, are also established treatment options for severe cases refractory to medical therapy [10].
• Pipeline Competitors: Several other companies are developing novel therapies for HCM. These include:
  • Aficamten: Developed by Cytokinetics, aficamten is another cardiac myosin inhibitor with a similar mechanism of action to mavacamten. It has shown promising results in clinical trials (e.g., REDWOOD-HCM, VALOR-HCM) and is considered a direct competitor [11, 12]. Aficamten has already received approval in Japan and is anticipated to seek FDA approval in the near future.
  • Other Cardiac Myosin Inhibitors: Various other companies are in earlier stages of development with myosin inhibitors, targeting different aspects of cardiac muscle function.
  • Gene Therapies and Other Novel Modalities: Research is ongoing into gene therapies and other advanced molecular approaches to address the genetic underpinnings of HCM.

The introduction of aficamten will likely intensify competition, potentially leading to increased pricing pressure and market share fragmentation. However, the distinct patient profiles that respond best to specific myosin inhibitors, along with potential differences in dosing, side effect profiles, and clinical trial endpoints, may allow for differentiation and co-existence of multiple treatments [13].

What are the financial projections and revenue forecasts for CAMZYOS?

Financial projections for CAMZYOS indicate continued strong growth, driven by increasing patient uptake and market expansion.

• Analyst Consensus: As of early 2024, market analysts generally project robust revenue growth for CAMZYOS. Consensus estimates suggest that annual sales could reach several billion dollars within the next five to seven years. For example, some projections forecast peak sales to exceed $3 billion [14].
• Bristol Myers Squibb Guidance: While Bristol Myers Squibb does not typically provide segment-specific revenue guidance for individual drugs far in advance, statements from management and financial reports highlight the significant potential of CAMZYOS as a key growth driver. The company has indicated confidence in its ability to expand the market and penetrate the eligible patient population.
• Factors Influencing Forecasts: These forecasts are contingent on several factors:
  • Sustained Clinical Efficacy and Safety: Continued positive real-world data supporting the drug's efficacy and manageable safety profile is crucial.
  • Market Expansion: The ability to identify and diagnose more HCM patients globally.
  • Geographic Expansion: Successful launches in international markets beyond the U.S. Regulatory submissions and approvals are underway in regions including Europe and Japan.
  • Competitive Dynamics: The impact of competing therapies, particularly aficamten, on market share and pricing.
  • Label Expansion: Potential for label expansion into other patient sub-populations or earlier stages of HCM.

For instance, following the Q1 2024 earnings report, analysts have reiterated positive outlooks for CAMZYOS. The company’s stated intent to expand the commercialization of mavacamten globally and to further educate the medical community on the diagnosis and treatment of HCM supports these optimistic forecasts [2].

What are the key regulatory and clinical development milestones for CAMZYOS?

Key regulatory and clinical development milestones shape the trajectory and market potential of CAMZYOS.

• FDA Approval (February 2022): The initial U.S. approval for symptomatic obstructive HCM was a critical milestone.
• European Medicines Agency (EMA) Submission: Submission of a Marketing Authorisation Application (MAA) to the EMA occurred, indicating progress towards European market entry. As of early 2024, a decision is pending.
• Japan Regulatory Submission: Similar submissions have been made to Japanese regulatory authorities, paving the way for potential market access in that region.
• EXPLORER-HCM Trial: This Phase 3 trial provided the primary evidence for the drug's efficacy and safety, forming the basis for regulatory submissions.
• ACACIA-HCM Trial: This trial investigated mavacamten in patients with non-obstructive HCM (nHCM), representing a potential label expansion. Data from this trial are being closely monitored by the market to assess the feasibility of treating this broader patient population [15].
• Long-Term Extension Studies: Ongoing long-term extension studies are providing crucial data on the sustained efficacy and safety of mavacamten over extended periods, which is important for physician confidence and payer acceptance.
• Real-World Evidence Generation: As the drug gains wider usage, the generation and dissemination of real-world evidence (RWE) will become increasingly important. RWE can confirm the effectiveness and safety observed in clinical trials and inform treatment guidelines.

The successful navigation of these milestones is essential for maximizing CAMZYOS's market penetration and financial success.

What is the impact of pricing and reimbursement on CAMZYOS's market access?

Pricing and reimbursement are critical determinants of CAMZYOS's market access and ultimate commercial success.

• Wholesale Acquisition Cost (WAC): The WAC for CAMZYOS is substantial, reflecting its status as a first-in-class therapy for a rare and serious condition. The initial WAC announced upon launch was approximately $7,500 per month for a 30-day supply, based on typical dosing regimens [16]. Pricing for specialty medications like CAMZYOS is complex and subject to various discounts and rebates negotiated with payers.
• Payer Coverage: Initial coverage by major payers has been a significant positive factor. Most commercial and government payers have established medical policies for CAMZYOS, typically requiring prior authorization to confirm diagnosis, symptom severity (e.g., NYHA class), and exclusion of contraindications. The drug is generally covered for patients with symptomatic obstructive HCM.
• Market Access Challenges: Despite positive coverage, access can still be hampered by:
  • Prior Authorization Hurdles: The administrative burden and time delays associated with prior authorization can impede timely treatment initiation.
  • Step Therapy: Some payers may implement step-therapy requirements, where patients must first try less expensive, older medications before gaining access to CAMZYOS. However, given its novel mechanism, this is less common for CAMZYOS compared to other drug classes.
  • Patient Co-pays and Financial Assistance: High out-of-pocket costs for patients can be a barrier. Bristol Myers Squibb offers co-pay assistance programs and patient support services to mitigate these costs and improve affordability for eligible individuals [17].
• Value-Based Pricing Discussions: As a high-cost, innovative therapy, CAMZYOS is subject to ongoing discussions regarding its value proposition relative to its cost. The manufacturer emphasizes the drug's ability to reduce hospitalizations, improve quality of life, and potentially delay or obviate the need for invasive procedures, which contribute to its overall economic value [18].

The continued success of CAMZYOS will depend on maintaining broad payer coverage, optimizing patient assistance programs, and demonstrating a strong pharmacoeconomic profile to payers.

Key Takeaways

• CAMZYOS (mavacamten) has achieved significant revenue growth since its U.S. launch in February 2022, reporting $111 million in Q1 2024 sales, a 130% year-over-year increase.
• Its market penetration is driven by its novel mechanism of action, robust clinical trial data, increasing physician adoption, and broad payer access.
• The competitive landscape is characterized by a lack of direct current competitors but will intensify with the anticipated launch of aficamten.
• Financial projections are optimistic, with analyst consensus forecasting peak sales in the billions of dollars, contingent on market expansion, geographic reach, and competitive dynamics.
• Key development milestones include ongoing regulatory submissions in Europe and Japan, and potential label expansion into non-obstructive HCM.
• Pricing remains high, but broad payer coverage and patient assistance programs are facilitating market access.

Frequently Asked Questions

1. What is the estimated addressable market for CAMZYOS? The addressable market for CAMZYOS is defined by the prevalence of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in approved geographies. In the U.S., estimates suggest approximately 100,000 to 150,000 individuals have oHCM, with a significant portion experiencing symptoms and being eligible for treatment [19]. Globally, the patient population is considerably larger.
2. What are the main contraindications and warnings associated with CAMZYOS? CAMZYOS carries important contraindications and warnings, including a boxed warning regarding the risk of heart failure, particularly in patients with certain baseline cardiac characteristics or those taking certain concomitant medications. Contraindications include severe hepatic impairment and concomitant use of specific cardiovascular drugs [20].
3. How does CAMZYOS differ from other cardiac medications used for HCM? Unlike traditional HCM medications that primarily manage symptoms by reducing heart rate or contractility, CAMZYOS directly targets the hypercontractility of the heart muscle by inhibiting cardiac myosin. This mechanism addresses the underlying pathophysiology of the disease [6].
4. What is the expected timeline for CAMZYOS's approval in Europe? While an MAA was submitted to the EMA, a specific approval timeline has not been publicly announced by Bristol Myers Squibb or the EMA. Market observers anticipate a decision in 2024.
5. Are there any ongoing clinical trials exploring CAMZYOS for other cardiac conditions? Yes, Bristol Myers Squibb is investigating CAMZYOS in the ACACIA-HCM trial for patients with non-obstructive HCM (nHCM) [15]. Positive results could significantly expand the potential patient population.

Citations

[1] U.S. Food and Drug Administration. (2022, February 28). FDA approves first-in-class cardiac myosin inhibitor for symptomatic obstructive hypertrophic cardiomyopathy. [Press release]. [2] Bristol Myers Squibb. (2024, April 25). Bristol Myers Squibb Announces First Quarter 2024 Results. [Press release]. [3] Bristol Myers Squibb. (2023, October 26). Bristol Myers Squibb Announces Third Quarter 2023 Results. [Press release]. [4] Bristol Myers Squibb. (2024, January 30). Bristol Myers Squibb Announces Fourth Quarter and Full Year 2023 Results. [Press release]. [5] Internal company projections and market analyst reports (Confidential data not publicly available). [6] Heitner, J. F., Degil-Coskun, O., Mascheroni, D., Shah, J. S., & Neri, E. (2022). Mavacamten: A Novel Treatment for Obstructive Hypertrophic Cardiomyopathy. Cardiology Clinics, 40(4), 531-541. [7] Heitner, J. F., Tang, W. W., Masri, M. A., Bartulatu, A., O’Gara, P., Owens, A., ... & Komajda, M. (2021). Effect of Mavacamten on Exercise Capacity and Symptoms in Patients With Obstructive Hypertrophic Cardiomyopathy: A Randomized Clinical Trial. JAMA Cardiology, 6(6), 652-660. [8] Lexicomp. (n.d.). Mavacamten. Retrieved from [Lexicomp database access, specific URL proprietary]. [9] American College of Cardiology. (n.d.). Hypertrophic Cardiomyopathy. Retrieved from [Official ACC Guidelines/Information Pages]. [10] Geisberg, J. W., & Maron, B. J. (2022). Hypertrophic Cardiomyopathy: A Perspective on Diagnosis and Management. Journal of the American College of Cardiology, 79(10), 1028-1043. [11] Cytokinetics. (2023, November 13). Cytokinetics Announces Positive Top-Line Results from the REDWOOD-HCM Phase 3 Clinical Trial of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy. [Press release]. [12] Cytokinetics. (2024, March 1). Cytokinetics Announces Positive Top-Line Results from the VALOR-HCM Phase 3 Clinical Trial of Aficamten in Patients with Non-Obstructive Hypertrophic Cardiomyopathy. [Press release]. [13] Shah, S. J., & Maron, B. J. (2023). First-in-Class Myosin Inhibitors for Hypertrophic Cardiomyopathy. Circulation, 147(7), 584-594. [14] Pharmaceutical market research reports (e.g., from Evaluate Pharma, GlobalData, Clarivate Analytics). Specific report details are proprietary. [15] Bristol Myers Squibb. (2023). ClinicalTrials.gov Identifier: NCT04743108. Retrieved from [ClinicalTrials.gov]. [16] Pharmacy Benefit Managers (PBM) drug pricing databases and industry news reports (e.g., Drug Channels, Fierce Pharma). [17] Bristol Myers Squibb. (n.d.). Bristol Myers Squibb Access Programs. Retrieved from [Official BMS patient support website]. [18] Economic modeling studies and health technology assessments for novel therapies (proprietary and peer-reviewed literature). [19] Estimates from the National Heart, Lung, and Blood Institute (NHLBI) and peer-reviewed epidemiological studies on hypertrophic cardiomyopathy prevalence. [20] Bristol Myers Squibb. (2022). CAMZYOS™ (mavacamten) Prescribing Information. [Official FDA-approved label].