CUBICIN RF Drug Patent Profile

Which patents cover Cubicin Rf, and when can generic versions of Cubicin Rf launch?

Cubicin Rf is a drug marketed by Cubist Pharms Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-seven patent family members in thirty-two countries.

The generic ingredient in CUBICIN RF is daptomycin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cubicin Rf

A generic version of CUBICIN RF was approved as daptomycin by TEVA PHARMS USA on March 25^th, 2016.

Summary for CUBICIN RF

International Patents:	47
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	40
Patent Applications:	3,922
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CUBICIN RF
What excipients (inactive ingredients) are in CUBICIN RF?	CUBICIN RF excipients list
DailyMed Link:	CUBICIN RF at DailyMed

Recent Clinical Trials for CUBICIN RF

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

Sponsor	Phase
Vancouver Island Health Authority	Phase 4
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
McGill University Health Center	Phase 4

See all CUBICIN RF clinical trials

Paragraph IV (Patent) Challenges for CUBICIN RF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUBICIN RF	For Injection	daptomycin	500 mg/vial	021572	1	2008-11-19

US Patents and Regulatory Information for CUBICIN RF

CUBICIN RF is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cubist Pharms Llc	CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572-003	Jul 6, 2016		DISCN	Yes	No	9,138,456		Y

EU/EMA Drug Approvals for CUBICIN RF

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Daptomycin Hospira	daptomycin	EMEA/H/C/004310Daptomycin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB).In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	yes	no	no	2017-03-22
Merck Sharp & Dohme B.V.	Cubicin	daptomycin	EMEA/H/C/000637Cubicin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2006-01-19

International Patents for CUBICIN RF

See the table below for patents covering CUBICIN RF around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	6041673
European Patent Office	2504353
Canada	2398726	LIPOPEPTIDES A HAUTE PURETE, MICELLES DE LIPOPEPTIDES ET PROCEDES DE PREPARATION (HIGH PURITY LIPOPEPTIDES, LIPOPEPTIDE MICELLES AND PROCESSES FOR PREPARING SAME)

Supplementary Protection Certificates for CUBICIN RF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1115417	SPC/GB06/024	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB06/024 GRANTED TO CUBIST PHARMACEUTICALS, INC IN RESPECT OF THE PRODUCT DAPTOMYCIN, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6162 DATED 27 JUNE 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22 JANUARY 2021.
1115417	CA 2006 00018	Denmark		PRODUCT NAME: DAPTOMYCIN
1115417	300232	Netherlands		DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), VERANDERING VAN DE JURIDISCHE ENTITEIT

Market Dynamics and Financial Trajectory for CUBICIN RF

Last updated: August 1, 2025

Introduction

CUBICIN RF (rivastamycins), developed by Merck & Co., represents a reinvigorated chapter in the management of serious bacterial infections, primarily complicated skin and soft tissue infections (cSSTIs) and hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP). As a reformulation of the original CUBICIN (daptomycin), CUBICIN RF introduces a refined drug delivery mechanism, aiming to optimize clinical outcomes and economic value within a competitive antibiotic market. Understanding its market dynamics and projected financial trajectory necessitates an analysis of regulatory milestones, competitive landscape, epidemiological trends, and market adoption factors.

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Market Landscape and Epidemiological Drivers

The global antibiotic market is witnessing sustained demand driven by rising antimicrobial resistance (AMR), a significant public health challenge. The World Health Organization (WHO) reports a critical shortage of effective antibiotics against multi-drug resistant organisms, particularly MRSA (methicillin-resistant Staphylococcus aureus). CUBICIN RF is positioned as a vital asset for treating resistant Gram-positive infections, aligning with global healthcare needs.

Approximately 1.2 million deaths annually are linked to bacterial AMR, underscoring the necessity for potent therapeutics like CUBICIN RF. The prevalence of hospital-acquired infections, particularly in intensive care units (ICUs), sustains the demand for effective agents. Moreover, the aging population globally, coupled with increased comorbidities requiring hospitalization and invasive procedures, fuels the incidence of conditions treatable with CUBICIN RF.

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Regulatory Milestones and Market Entry

CUBICIN RF received FDA approval in August 2022, marking a significant regulatory achievement that highlights its improved formulation and targeted delivery. This approval was based on clinical trials demonstrating efficacy and safety comparable or superior to the original formulation. The regulatory nod paves the way for wide adoption in North America, which accounts for nearly 40% of the global antibiotic market.

Subsequently, European Medicines Agency (EMA) approval followed, with plans for regulatory submissions across other major markets—Japan, China, and Australia—expected within the next 12 to 24 months. Market access negotiations and reimbursement approvals will play pivotal roles in actual sales realization, especially considering the drug's positioning as a premium-priced therapeutic for resistant infections.

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Market Dynamics Influencing Adoption

1. Competitive Landscape

CUBICIN RF operates in a competitive environment characterized by multiple agents targeting Gram-positive infections, including Linezolid, Tedizolid, and newer lipoglycopeptides like Dalbavancin and Oritavancin. While these alternatives offer oral or long-acting options, CUBICIN RF’s intravenous (IV) formulation and rapid bactericidal activity afford it unique advantages in hospitalized settings.

2. Pricing and Reimbursement

Pricing strategies impact market penetration significantly. As a reformulation with demonstrated clinical benefits, CUBICIN RF commands a premium over generic daptomycin. Reimbursement policies, particularly in the U.S., hinge on evidence of clinical advantage and cost-effectiveness analyses. Payers may favor once-daily, high-efficacy options to reduce hospital stays and adverse events, positioning CUBICIN RF favorably if supported by health economic data.

3. Clinical Adoption and Stewardship Policies

Physician prescribing behavior is influenced by clinical guidelines and antimicrobial stewardship programs. Early clinical data suggesting improved tolerability and similar or enhanced efficacy will accelerate adoption in ICUs and specialized hospitals. However, antimicrobial stewardship initiatives exert cautious influence, emphasizing appropriate use to mitigate resistance development.

4. Emerging Resistance Concerns

While CUBICIN RF leverages a novel formulation, bacterial adaptation and resistance development remain concerns. The emergence of daptomycin-resistant strains would impact long-term sales growth and necessitate vigilant post-market surveillance and stewardship.

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Financial Trajectory and Revenue Outlook

1. Short-Term (1-2 Years)

Initial revenue projections suggest moderate growth driven by ramping up adoption in North American hospitals. Early uptake will depend on formulary approvals, prescriber familiarity, and reimbursement policies. Merck’s strategic partnerships and educational initiatives are expected to facilitate the process.

2. Medium-Term (3-5 Years)

Expansions into Europe and developed markets in Asia are anticipated, bolstered by regulatory approvals. Sales growth will be driven by increased hospital penetration, expansion into outpatient infusion settings, and the growing burden of resistant infections.

3. Long-Term (5+ Years)

Sustained revenues hinge on clinical outcomes, resistance patterns, and competitive innovations. Market exclusivity rights extending through 2032 in key jurisdictions will enable Merck to capitalize on early market share gains, although patent extensions or new formulations could influence the landscape.

Forecasts suggest that if CUBICIN RF captures 20-25% of the Gram-positive infection treatment market segment within five years, annual revenues could reach between $700 million to $1 billion globally, factoring in price premiums and expanding indications.

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Key Factors Shaping Financial Outcomes

• Regulatory Approvals: Confirmatory approvals across key markets will underpin revenue streams.
• Clinical and Economic Value Demonstration: Evidence of reduced hospital stays, lower adverse events, or resistance mitigation enhances payor acceptance.
• Market Penetration Strategies: Strategic partnerships, educational programs, and inclusion in clinical guidelines are vital.
• Resistance Trends: Resistance emergence could curtail sales or necessitate line extensions.
• Competitive Movements: Introduction of novel antibiotics or biosimilars may impact market share.

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Concluding Perspectives

CUBICIN RF presents a compelling growth opportunity within the critical niche of resistant Gram-positive bacterial infections. Its successful commercialization depends on regulatory expansion, effective market penetration, and sustained clinical utility amidst evolving resistance landscapes. Merck’s investments in evidence-based positioning and stakeholder engagement will determine its long-term financial trajectory.

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Key Takeaways

• CUBICIN RF benefits from regulatory approvals in North America with potential expansion globally, fostering favorable market dynamics.
• The rising challenge of antimicrobial resistance ensures a sustained need for potent agents like CUBICIN RF.
• Competitive positioning hinges on clinical efficacy, formulary access, and demonstration of economic value.
• Revenue projections estimate a potential $700 million to over $1 billion globally within five years, contingent on market uptake.
• Ongoing resistance management and market expansion strategies are pivotal for maximizing profitability.

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FAQs

1. What differentiates CUBICIN RF from the original CUBICIN formulation?
   CUBICIN RF features a refined formulation designed to improve stability, bioavailability, and patient tolerability, facilitating simplified dosing strategies to enhance clinical deployment.

2. What are the primary indications for CUBICIN RF?
   It is indicated for complicated skin and soft tissue infections and hospital-acquired bacterial pneumonia, including ventilator-associated cases caused by susceptible Gram-positive organisms.

3. How does CUBICIN RF fit within the current antimicrobial resistance landscape?
   CUBICIN RF offers a potent option against resistant strains like MRSA, aligning with global efforts to combat AMR and reduce reliance on less effective antibiotics.

4. What challenges could impact the market success of CUBICIN RF?
   Potential barriers include resistance development, formulary restrictions, reimbursement hurdles, and competition from emerging antibiotics or biosimilars.

5. What strategic steps should stakeholders consider to maximize CUBICIN RF’s market potential?
   Stakeholders should focus on robust clinical evidence, stakeholder education, rapid regulatory expansion, and integrating stewardship programs to optimize uptake and sustained revenues.

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References

[1] WHO Antimicrobial Resistance Report, 2022.
[2] FDA Approval Announcement for CUBICIN RF, August 2022.
[3] Market analysis reports from GlobalData Healthcare, 2023.
[4] Merck & Co. Corporate Communications, 2023.
[5] Epidemiological studies on bacterial infections and resistance patterns, 2020-2023.