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-nine 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:	21
Clinical Trials:	40
Patent Applications:	2,451
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/004310 Daptomycin 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/000637 Cubicin 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
Denmark	1115417
European Patent Office	1115417	UTILISATION DE DAPTOMYCIN (USE OF DAPTOMYCIN)
Canada	1315229	PROCEDE DE PURIFICATION CHROMATOGRAPHIQUE (CHROMATOGRAPHIC PURIFICATION PROCESS)
Iceland	6470

Supplementary Protection Certificates for CUBICIN RF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1115417	06C0022	France		PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
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	22/2006	Austria		PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
1115417	CA 2006 00018	Denmark		PRODUCT NAME: DAPTOMYCIN

Market Dynamics and Financial Trajectory for CUBICIN RF (Daptomycin)

Overview of CUBICIN RF

CUBICIN RF, also known as daptomycin, is a potent antibiotic used to treat complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bloodstream infections (bacteremia), including those caused by methicillin-resistant strains[1][4].

Market Size and Growth

The daptomycin market, which includes CUBICIN RF, was valued at USD 3.81 billion in 2023. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.73% from 2024 to 2030, reaching approximately USD 4.92 billion by 2030[3].

Key Drivers of Market Growth

Increasing Prevalence of Antibiotic-Resistant Infections

The rise in hospital-acquired infections (HAIs) and the growing resistance of bacteria to multiple antibiotics are significant drivers of the daptomycin market. Daptomycin's effectiveness against Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), makes it a crucial option in treating these infections[3].

Expanding Clinical Uses

Ongoing clinical trials and research are exploring additional uses for daptomycin, further propelling market growth. The drug's approval for pediatric indications in patients aged 1 to 17 years for cSSSI and bacteremia has also expanded its market reach[1][4].

Growing Awareness Among Healthcare Providers and Patients

Increased awareness about the efficacy of daptomycin in treating infections caused by antibiotic-resistant bacteria is driving its adoption. This awareness is particularly significant among healthcare providers and patients who are seeking safer and more effective treatment options[3].

Market Segmentation

By Age Group

The daptomycin market is segmented into pediatric and adult populations. The adult segment currently generates the highest revenue, primarily due to the treatment of bacteremia and right-sided infective endocarditis. However, the pediatric segment is also growing, supported by the recent approval for pediatric indications[3].

By Indication

The market is segmented by indications such as complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bloodstream infections (bacteremia). These indications are critical in driving the demand for daptomycin[3][4].

By Strength

CUBICIN RF is available in various strengths, including 350mg and 500mg single-dose vials. The availability of different strengths caters to different patient needs and treatment protocols[3].

Competitive Landscape

Key Players

The daptomycin market is competitive, with key players including Merck & Co., Teva Pharmaceutical Industries, Pfizer, Cipla, Dr. Reddy’s Laboratories, and others. These companies are investing significantly in research and development to expand their product lines and improve treatment outcomes[3].

Recent Developments

• Generic Launch: In May 2024, Dr. Reddy’s Laboratories launched a generic version of daptomycin for injection in the U.S. market, which is expected to increase market competition and improve accessibility[3].
• Product Recall: Merck initiated a recall of their Cubicin (daptomycin) product in May 2024 due to contamination with particulate matter, highlighting the importance of stringent quality control measures[3].

Challenges and Limitations

High Cost and Potential Adverse Effects

Despite its efficacy, the high cost of daptomycin and potential adverse effects, such as myopathy and elevations in creatine phosphokinase (CPK), are challenges that hamper market growth. Patients with renal impairment or those taking other medications associated with myopathy require close monitoring[4].

Regulatory Considerations

The safety and efficacy of CUBICIN RF in patients with severe renal impairment (creatinine clearance < 30 mL/min) have not been established, which can limit its use in certain patient populations[4].

Financial Trajectory

Revenue Projections

The projected growth of the daptomycin market from USD 3.81 billion in 2023 to USD 4.92 billion by 2030 indicates a stable financial trajectory. This growth is driven by increasing demand, expanding clinical uses, and the launch of generic versions which can make the drug more accessible[3].

Investment in Research and Development

Leading pharmaceutical companies are investing significantly in research and development to improve treatment outcomes and address emerging challenges in antibiotic resistance. These investments are expected to further drive the market growth and financial performance of daptomycin[3].

Regional Insights

The daptomycin market is global, with significant presence in regions where antibiotic-resistant infections are prevalent. The market dynamics vary by region, influenced by local healthcare policies, patient awareness, and the availability of alternative treatments[3].

Key Takeaways

• The daptomycin market, including CUBICIN RF, is growing due to the increasing prevalence of antibiotic-resistant infections and expanding clinical uses.
• The market is segmented by age group, indication, and strength, with the adult segment currently generating the highest revenue.
• Key players are investing in research and development to improve treatment outcomes and address emerging challenges.
• High cost and potential adverse effects are challenges that need to be managed.
• The market is expected to grow at a CAGR of 3.73% from 2024 to 2030.

FAQs

What are the primary indications for CUBICIN RF?

CUBICIN RF is primarily indicated for the treatment of complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bloodstream infections (bacteremia), including those caused by methicillin-resistant strains[1][4].

What is the expected market size of daptomycin by 2030?

The daptomycin market is expected to reach approximately USD 4.92 billion by 2030, growing at a CAGR of 3.73% from 2024 to 2030[3].

Who are the key players in the daptomycin market?

Key players include Merck & Co., Teva Pharmaceutical Industries, Pfizer, Cipla, Dr. Reddy’s Laboratories, and others[3].

What are the challenges associated with the use of CUBICIN RF?

The high cost and potential adverse effects, such as myopathy and elevations in creatine phosphokinase (CPK), are significant challenges associated with the use of CUBICIN RF[4].

Has CUBICIN RF been approved for pediatric use?

Yes, CUBICIN RF has been approved for pediatric indications in patients aged 1 to 17 years for the treatment of cSSSI and Staphylococcus aureus bloodstream infections[1][4].

Sources

1. Regulatory Decision Summary for Cubicin, Cubicin RF - Health Canada[1]
2. Daptomycin Market: Global Industry Analysis and Forecast (2024-2030) - Stellar Market Research[3]
3. CUBICIN®/CUBICIN® RF - PRODUCT MONOGRAPH - Health Canada[4]
4. Generic DAPTOMYCIN INN equivalents, pharmaceutical patent and market dynamics - Drug Patent Watch[5]