DAPTOMYCIN IN 0.9% SODIUM CHLORIDE Drug Patent Profile

When do Daptomycin In 0.9% Sodium Chloride patents expire, and what generic alternatives are available?

Daptomycin In 0.9% Sodium Chloride is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in DAPTOMYCIN IN 0.9% SODIUM CHLORIDE is daptomycin. There are ten drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Daptomycin In 0.9% Sodium Chloride

A generic version of DAPTOMYCIN IN 0.9% SODIUM CHLORIDE was approved as daptomycin by TEVA PHARMS USA on March 25^th, 2016.

Summary for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	92
DailyMed Link:	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

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

Sponsor	Phase
Chang Gung Memorial Hospital	N/A
Pfizer	Phase 2
University Magna Graecia	Phase 4

See all DAPTOMYCIN IN 0.9% SODIUM CHLORIDE clinical trials

Pharmacology for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Drug Class

Lipopeptide Antibacterial

US Patents and Regulatory Information for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-005	Feb 27, 2023		RX	Yes	Yes
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-004	Feb 27, 2023		RX	Yes	Yes
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-002	Feb 27, 2023		RX	Yes	Yes
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-003	Feb 27, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

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 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

See the table below for patents covering DAPTOMYCIN IN 0.9% SODIUM CHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2021233893	Daptomycin formulations containing a combination of sorbitol and mannitol
World Intellectual Property Organization (WIPO)	2021183752
China	115243675	含有山梨糖醇和甘露糖醇的组合的达托霉素制剂 (Daptomycin formulations containing combination of sorbitol and mannitol)
Brazil	112022015170	FORMULAÇÕES DE DAPTOMICINA CONTENDO UMA COMBINAÇÃO DE SORBITOL E MANITOL
Canada	3170514	FORMULATIONS DE DAPTOMYCINE CONTENANT UNE ASSOCIATION DE SORBITOL ET DE MANNITOL (DAPTOMYCIN FORMULATIONS CONTAINING A COMBINATION OF SORBITOL AND MANNITOL)
Japan	2023517926	ソルビトールとマンニトールの組み合わせを含むダプトマイシン製剤
European Patent Office	4117625	FORMULATIONS DE DAPTOMYCINE CONTENANT UNE ASSOCIATION DE SORBITOL ET DE MANNITOL (DAPTOMYCIN FORMULATIONS CONTAINING A COMBINATION OF SORBITOL AND MANNITOL)

Supplementary Protection Certificates for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1115417	CA 2006 00018	Denmark		PRODUCT NAME: DAPTOMYCIN
1115417	SZ 22/2006	Austria		PRODUCT NAME: DAPTOMYCIN
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

DAPTOMYCIN IN 0.9% SODIUM CHLORIDE Market Analysis and Financial Projection

Daptomycin in 0.9% Sodium Chloride Injection: Market Dynamics and Financial Trajectory

Market Overview

Daptomycin, marketed as Cubicin or Daptomycin in Sodium Chloride Injection, is a cyclic lipopeptide antibacterial drug that has gained significant traction in the pharmaceutical market. Here’s a detailed look at its market dynamics and financial trajectory.

Market Size and Growth

As of 2023, the daptomycin market was valued at USD 3.81 billion. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.73% from 2024 to 2030, reaching nearly USD 4.92 billion by 2030[3].

Driving Factors

Several factors are driving the growth of the daptomycin market:

Antibiotic Resistance

The increasing prevalence of antibiotic-resistant gram-positive bacteria, such as MRSA, is a significant driver. Daptomycin remains effective against these resistant strains, making it a crucial option in the fight against antibiotic resistance[3].

Aging Population

The aging population is more susceptible to infections, and daptomycin is often used to treat serious bacterial infections in this demographic. This increased susceptibility contributes to the drug's growing market[3].

Clinical Trials and Research

Ongoing clinical trials and research into new applications and combinations of daptomycin are expanding its market reach. These efforts aim to further elucidate the drug's potential and address emerging challenges in antibiotic resistance[3].

Government Initiatives

Government programs and funding aimed at preventing antibiotic resistance and promoting the development of new antibiotics also support the growth of the daptomycin market[3].

Market Challenges

Despite the growth, there are several challenges that impact the market:

High Cost

Daptomycin is relatively expensive compared to other antibiotics, which limits its use, especially in regions with limited healthcare resources. For example, the cost for a 70 kg patient over 14 days can be as high as $1,199.20, excluding the cost of wasted drug[2].

Potential Adverse Effects

Daptomycin can cause side effects such as kidney damage, muscle pain, and eosinophilic pneumonia, although these are rare. These potential adverse effects necessitate careful prescription and monitoring by healthcare providers[5].

Regulatory Hurdles

Strict legal and regulatory requirements in the development and introduction of new antibiotics can lead to delays and additional costs. This can affect the market potential of daptomycin and other antimicrobials[3].

Market Segmentation

The daptomycin market is segmented based on several factors:

Age Group

The market is divided into pediatric and adult segments. The use of daptomycin in treating adult patients with bacteremia and right-sided infective endocarditis generates the highest market revenue. The pediatric segment also sees significant use, particularly for complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bloodstream infections[3].

Regional Insight

The market varies by region, with different regions experiencing different levels of demand based on factors such as the prevalence of antibiotic-resistant infections and healthcare infrastructure.

Competitive Landscape

The competitive landscape of the daptomycin market is dynamic:

Generic Versions

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 for healthcare providers and patients[3].

Product Recalls

Merck initiated a recall of their Cubicin (daptomycin) product due to contamination with particulate matter, highlighting the importance of stringent quality control measures in pharmaceutical manufacturing[3].

Research and Development

Leading pharmaceutical companies such as Teva Pharmaceuticals, Merck, Pfizer, and Cipla are investing significantly in research and development to expand their product lines and address emerging challenges in antibiotic resistance[3].

Financial Considerations

Cost Analysis

The cost of daptomycin is a significant factor in its market dynamics. For instance, the cost per 500mg vial is $152, which translates to $1,191.68 for a 14-day treatment for a 70 kg patient, excluding the cost of wasted drug[2].

Revenue Projections

Given the projected CAGR of 3.73%, the revenue from daptomycin is expected to increase steadily over the next few years, driven by its efficacy against resistant bacterial infections and ongoing research into new applications.

Key Takeaways

• Market Growth: The daptomycin market is expected to grow at a CAGR of 3.73% from 2024 to 2030.
• Driving Factors: Antibiotic resistance, an aging population, and ongoing clinical trials are key drivers.
• Challenges: High cost, potential adverse effects, and regulatory hurdles are significant challenges.
• Market Segmentation: The market is segmented by age group and region.
• Competitive Landscape: Generic versions, product recalls, and ongoing R&D activities shape the competitive landscape.

FAQs

What are the primary indications for daptomycin in 0.9% sodium chloride injection?

Daptomycin in 0.9% sodium chloride injection is indicated for the treatment of complicated skin and skin structure infections (cSSSI) in adult and pediatric patients, and Staphylococcus aureus bloodstream infections (bacteremia) in adult and pediatric patients[5].

What are the common adverse reactions associated with daptomycin?

Common adverse reactions include diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated creatine phosphokinase (CPK), urinary tract infections, hypotension, and dyspnea in adult patients. In pediatric patients, common reactions include diarrhea, vomiting, abdominal pain, pruritus, pyrexia, elevated CPK, and headache[5].

How does the cost of daptomycin compare to other antibiotics?

Daptomycin is relatively expensive compared to other antibiotics. For example, a 14-day treatment for a 70 kg patient can cost around $1,199.20, excluding the cost of wasted drug, which is significantly higher than other antibiotics like vancomycin[2].

What are the key factors driving the growth of the daptomycin market?

The growth of the daptomycin market is driven by the increasing prevalence of antibiotic-resistant infections, an aging population, ongoing clinical trials, and government initiatives to combat antibiotic resistance[3].

Are there any generic versions of daptomycin available?

Yes, in May 2024, Dr. Reddy’s Laboratories launched a generic version of daptomycin for injection in the U.S. market, which is a therapeutic equivalent to Cubicin and has been approved by the FDA[3].

Sources

1. FDA: NDA Summary Review: Daptomycin in Sodium Chloride Injection[1].
2. University of Nebraska Medical Center: Daptomycin (Cubicin)[2].
3. Stellar Market Research: Daptomycin Market: Global Industry Analysis and Forecast (2024-2030)[3].
4. Baxter: Daptomycin in Sodium Chloride Injection[4].
5. Baxter: Daptomycin Premix Sell Sheet[5].