CUBICIN Drug Patent Profile

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

Cubicin is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are two patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in CUBICIN 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

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

Summary for CUBICIN

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	40
Patent Applications:	4,494
Drug Prices:	Drug price information for CUBICIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CUBICIN
What excipients (inactive ingredients) are in CUBICIN?	CUBICIN excipients list
DailyMed Link:	CUBICIN at DailyMed

See drug prices for CUBICIN

Recent Clinical Trials for CUBICIN

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 clinical trials

US Patents and Regulatory Information for CUBICIN

CUBICIN 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	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003		DISCN	No	No
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003		DISCN	Yes	No	8,003,673
Cubist Pharms Llc	CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572-003	Jul 6, 2016		DISCN	Yes	No	9,138,456		Y

Expired US Patents for CUBICIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	RE39071
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	8,058,238
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003	5,912,226
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	6,852,689
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	5,912,226

EU/EMA Drug Approvals for CUBICIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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
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

International Patents for CUBICIN

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

Country	Patent Number	Title	Estimated Expiration
Australia	3097801
Canada	2344318	METHODES D'ADMINISTRATION D'ANTIBIOTIQUES (METHODS FOR ADMINISTRATION OF ANTIBIOTICS)
Cyprus	1118334
Mexico	2012005993	COMPOSICIONES DE LIPOPEPTIDO Y METODOS RELACIONADOS. (LIPOPEPTIDE COMPOSITIONS AND RELATED METHODS.)
Spain	2259845

Supplementary Protection Certificates for CUBICIN

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	22/2006	Austria		PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
1115417	91254	Luxembourg		91254, EXPIRES: 20210119
1115417	CA 2006 00018	Denmark		PRODUCT NAME: DAPTOMYCIN
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.

Market Dynamics and Financial Trajectory for CUBICIN (Daptomycin)

Market Overview

CUBICIN, also known as daptomycin, is a crucial antibiotic in the fight against gram-positive bacterial infections, particularly those resistant to other antibiotics. The market for daptomycin is driven by several key factors that influence its growth and financial trajectory.

Growing Demand for Effective Antibiotics

The increasing prevalence of antibiotic-resistant bacteria is a significant driver for the daptomycin market. As classical antibiotics lose their effectiveness, daptomycin's resistance to these resistant strains makes it a vital treatment option for infections such as endocarditis, bacteraemia, and complicated skin and skin structure infections (cSSSI)[1][3][4].

Market Size and Forecast

As of 2023, the daptomycin market was valued at USD 3.81 billion. It is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.73% from 2024 to 2030, reaching approximately USD 4.92 billion by 2030[1].

Key Market Drivers

Antibiotic Resistance and Aging Population

The rise in antibiotic-resistant infections and the increasing susceptibility of older people to serious bacterial infections are major drivers of the daptomycin market. Government programs aimed at preventing antibiotic resistance and funding for new antibiotic research also contribute to the market's growth[1][3].

Hospital-Acquired Infections (HAIs)

The increase in hospital-acquired infections, often caused by drug-resistant organisms, further boosts the demand for daptomycin. This is exacerbated by the growing awareness among patients and healthcare providers about the effectiveness of daptomycin in treating resistant bacterial infections[1].

Clinical Trials and Research

Ongoing clinical trials and research into daptomycin's potential uses are expanding its market reach. These efforts aim to elucidate more aspects of the drug and improve treatment outcomes, which in turn drive market growth[1].

Competitive Landscape

Key Players

The daptomycin market is competitive, with key players including Teva Pharmaceutical Industries, Merck & Co., Cipla, Pfizer, Dr. Reddy’s Laboratories, and others. These companies are investing significantly in research and development to expand their product lines and improve treatment outcomes[1].

Generic Versions and Market Competition

The launch of generic versions of daptomycin, such as Dr. Reddy’s Laboratories' generic daptomycin for injection in the U.S. market, is expected to increase market competition and improve accessibility for healthcare providers and patients[1].

Financial Performance

Historical Revenue

CUBICIN has shown significant revenue growth since its launch. For instance, by the second quarter of 2012, U.S. net product revenues for CUBICIN had reached $200.2 million, up 18.7% from the same period in 2011. Cumulative sales in the U.S. had surpassed $3.6 billion by that time[2].

Projected Peak Sales

Industry estimates suggest that peak year sales for CUBICIN in the U.S. could surpass $1 billion, driven by factors such as the persistence of MRSA, the slow decline in vancomycin effectiveness, and reasonable price increases[2].

Market Segments

Age Group and Indication

The market is segmented by age group (pediatrics and adults) and by indication (complicated skin and skin structure infections, bacteraemia, etc.). These segments are crucial for understanding the diverse patient pool and tailoring treatment strategies accordingly[1].

Strength and Geographic Markets

Daptomycin is available in different strengths (e.g., 350mg and 500mg) and is marketed across various geographic regions. The U.S. dominates the North American market, while Europe and Asia-Pacific are also significant regions due to the rising cases of MRSA and HA-MRSA[1][4].

Challenges and Restraints

High Cost and Potential Adverse Effects

Despite its efficacy, daptomycin faces challenges such as high costs compared to traditional antibiotics and potential side effects. These factors can limit its adoption and impact market growth[1][3].

Regulatory Challenges

Stringent regulatory requirements for drug approval and the need for stringent quality control measures to ensure patient safety are additional challenges. For example, Merck's recall of Cubicin due to contamination highlights the importance of quality control[1].

Patent Expirations and Generic Competition

The entry of generic products following patent expirations can also impact the market dynamics, increasing competition and potentially reducing the market share of branded products[3].

SWOT Analysis

Strengths

• Efficacy Against Antibiotic-Resistant Bacteria: Daptomycin's ability to combat drug-resistant bacteria is a significant strength.
• Strong R&D Capabilities: Market players' strong research and development capabilities help in expanding product lines and improving treatment outcomes.
• Increasing Healthcare Infrastructure: Investments in healthcare infrastructure, especially in developing economies, support market growth[3].

Weaknesses

• High Cost: The high cost of daptomycin therapy compared to traditional antibiotics is a major weakness.
• Potential Side Effects: The drug's potential side effects and limitations are other significant weaknesses.
• Regulatory Challenges: Stringent approval processes and regulatory requirements can hinder market growth[3].

Opportunities

• Untapped Markets: Emerging economies offer untapped potential for the daptomycin market.
• Collaborations for Combination Therapies: Collaborations for developing combination therapies can improve treatment outcomes.
• Antimicrobial Stewardship Programs: Increasing focus on antimicrobial stewardship programs can drive demand for daptomycin[3].

Threats

• Intense Competition: Competition from existing antibiotics and alternative treatment options is a significant threat.
• Patent Expirations: The entry of generic products following patent expirations can reduce market share.
• Adverse Events: Adverse events or safety concerns can negatively impact market perception[3].

Geographic Market Analysis

North America

The U.S. dominates the North American market due to the increasing occurrences of complicated skin and skin structure infections and the high level of research activities in the region[4].

Europe

Europe holds the second largest position in the daptomycin market, driven by rising cases of MRSA and the approval of expanded marketing authorizations for Cubicin[4].

Asia-Pacific

The Asia-Pacific region is expected to grow at the highest rate due to the increasing occurrences of healthcare-associated and community-associated MRSA[4].

Key Takeaways

• The daptomycin market is driven by the increasing prevalence of antibiotic-resistant infections and the growing demand for effective antibiotic treatments.
• The market is expected to grow at a CAGR of 3.73% from 2024 to 2030, reaching nearly USD 4.92 billion by 2030.
• Key players are investing in research and development to expand product lines and improve treatment outcomes.
• High costs, potential side effects, and regulatory challenges are significant restraints on the market.
• Emerging economies and collaborations for combination therapies offer opportunities for market growth.

FAQs

What is the current market size of daptomycin and its projected growth?

The daptomycin market was valued at USD 3.81 billion in 2023 and is expected to grow at a CAGR of 3.73% from 2024 to 2030, reaching nearly USD 4.92 billion by 2030[1].

What are the main drivers of the daptomycin market?

The main drivers include the increasing prevalence of antibiotic-resistant infections, the growing geriatric population susceptible to infections, and the expansion of healthcare infrastructure in developing economies[1][3].

Who are the key players in the daptomycin market?

Key players include Teva Pharmaceutical Industries, Merck & Co., Cipla, Pfizer, Dr. Reddy’s Laboratories, and others[1].

What are the challenges facing the daptomycin market?

Challenges include the high cost of daptomycin therapy, potential side effects, stringent regulatory requirements, and the entry of generic products following patent expirations[1][3].

How does the geographic distribution of the daptomycin market look?

The U.S. dominates the North American market, Europe holds the second largest position, and the Asia-Pacific region is expected to grow at the highest rate due to increasing occurrences of MRSA[4].

Sources

1. Stellar Market Research: Daptomycin Market: Industry Analysis 2030.
2. Capital IQ: Cubist Pharmaceuticals Corporate Presentation September 2012.
3. Market Wide Research: Daptomycin market 2024-2032 | Size, Share, Growth.
4. Data Bridge Market Research: Global Daptomycin Market – Industry Trends and Forecast to 2028.