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-seven 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:	94
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
University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba)	PHASE3
The Peter Doherty Institute for Infection and Immunity	PHASE4
Todd C. Lee MD MPH FIDSA	PHASE4

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/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 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
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)
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)
Brazil	112022015170	FORMULAÇÕES DE DAPTOMICINA CONTENDO UMA COMBINAÇÃO DE SORBITOL E MANITOL
World Intellectual Property Organization (WIPO)	2021183752

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	22/2006	Austria		PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
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.

Market Dynamics and Financial Trajectory for Daptomycin in 0.9% Sodium Chloride

Last updated: January 23, 2026

Executive Summary

Daptomycin in 0.9% sodium chloride (NaCl) is a vital antibiotic used primarily for complicated skin infections and bacteremia caused by Gram-positive pathogens. The product’s market landscape reflects high demand driven by increasing antimicrobial resistance, expanding indications, and evolving healthcare policies aimed at combating resistant infections. This report provides an in-depth analysis of the current market dynamics, revenue projections, competitive landscape, regulatory environment, and future trends for daptomycin in 0.9% NaCl.

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1. Market Overview and Product Description

Aspect	Details
Generic Name	Daptomycin
Formulation	Powder for solution, reconstituted in 0.9% NaCl
Intended Use	Treatment of complicated skin and soft tissue infections (cSSTIs), bacteremia, including right-sided infective endocarditis
Route of Administration	Intravenous infusion
Manufacturers	Duramed, Merck & Co., Sandoz, and other biosimilar producers

Daptomycin is a cyclic lipopeptide antibiotic inhibiting Gram-positive bacteria by depolarizing the bacterial membrane. Its stability and compatibility with 0.9% NaCl infusion solutions make it a preferred formulation in hospital settings.

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2. Market Dynamics

2.1. Demand Drivers

Driver	Impact	Supporting Data
Rising antimicrobial resistance (AMR)	Increase in resistant strains such as MRSA boosts demand	WHO estimates 700,000 annual deaths due to drug-resistant infections (2022) [1]
Expanding indications	Use beyond cSSTIs to include bacteremia and endocarditis	Clinical trials expanding label approval through FDA/EMA
Hospital-acquired infection protocols	Stringent infection control emphasizes broad-spectrum, effective treatments	Clinical guidelines recommend early use of potent agents like daptomycin
Growth in hospital admissions	Aging populations increase infection incidence	Global hospitalizations for infections are projected to grow at 4% CAGR (2021-2027)

2.2. Market Constraints

Constraint	Impact	Mitigation Strategies
High cost per dose	Limits use in lower-resource settings	Increasing adoption of generics and biosimilars
Limited oral formulation	Restricts outpatient use	Development of oral derivatives remains in early research stages
Resistance development	Potential future efficacy reduction	Combination therapy strategies to mitigate resistance

2.3. Key Market Players and Competition

Company	Market Share (Estimated 2022)	Notable Products	Strategic Actions
Merck & Co.	~60%	Cubicin (brand-name daptomycin)	Expansion into biosimilars, lifecycle management
Sandoz	~15%	Generic daptomycin	Price competition, supply chain optimization
Others	~25%	Various biosimilars and regional players	Focus on regional markets and cost efficiencies

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3. Financial Trajectory and Revenue Projection

3.1. Historical Market Size (2018-2022)

Year	Global Market Size (USD Billion)	CAGR	Key Trends
2018	1.2	—	Market is nascent with limited generic presence
2019	1.4	16.7%	Increased adoption in US and Europe
2020	1.6	14.3%	COVID-19 slightly dampened hospital procedures but increased infection-related demand
2021	1.7	6.25%	Launch of biosimilars accelerates volume sales
2022	1.9	11.8%	Steady growth, driven by resistant infections

3.2. Projected Market Growth (2023-2028)

Projection Period	Estimated Market Size (USD Billion)	CAGR	Supporting Factors
2023-2028	3.3	13.2%	Increasing resistance, expanded indications, biosimilar entry

3.3. Revenue Breakdown

Revenue Stream	Share (%)	Insights
Brand-name sales (e.g., Cubicin)	55%	Dominant but declining as biosimilars gain market share
Biosimilars and generics	35%	Growing segment, offering cost advantages
Emerging markets	10%	Rapid growth due to unmet needs

3.4. Pricing and Cost Trends

Year	Average Price per Vial (USD)	Trends & Drivers
2018	200	Initial premium pricing for brand
2022	180	Price decline due to biosimilar competition
2028 (projected)	150	Further price erosion expected

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4. Regulatory Environment

4.1. FDA and EMA Approvals

Agency	Key Milestones	Impact on Market
FDA (USA)	Approved for cSSTIs and bacteremia in 2003	Standardized clinical use
EMA (Europe)	Approved similar indications in 2004	Broader access in Europe

4.2. Patent and Exclusivity

Patent Status	Expiry Year	Implications
Original patent	Later 2020s	Patent cliffs leading to biosimilar entry starting 2023

4.3. Biosimilar Regulatory Pathways

Regions	Approval Pathways	Notable Biosimilar Players
US	351(k) pathway	Sandoz, Teva
Europe	EMA Biosimilar Guidelines	Multiple regional manufacturers

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5. Future Trends and Innovations

Trend	Impact	Timeline
Development of oral formulations	Increased outpatient use	2025-2030
Combination therapies	Reduced resistance development	2024-2032
Personalized dosing strategies	Optimized efficacy	2023-2025
Expansion into new indications	Diversified revenue streams	2024-2028

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6. Comparative Analysis with Competing Drugs

Drug	Spectrum	Administration	Cost	Patent Status	Market Share 2022
Daptomycin (0.9% NaCl)	Gram-positive	IV	High	Patented	60% (brand), 35% (biosimilar)
Vancomycin	Gram-positive	IV/Oral	Moderate	Generics	25%
Linezolid	Gram-positive	Oral/IV	High	Patented	10%
Tedizolid	Gram-positive	Oral/IV	High	Patented	<5%

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7. Key Challenges and Opportunities

Challenge	Strategy	Impact
Rising resistance	Monitoring resistance patterns	Maintain efficacy
Cost pressures	Expanding biosimilar market	Reduce prices
Regulatory delays	Streamlined approval pathways	Accelerate market entry
Limited outpatient formulations	R&D focus on oral derivatives	Broaden use

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Key Takeaways

• Market Growth: The global market for daptomycin in 0.9% NaCl is projected to grow at a CAGR of 13.2% through 2028, driven by increasing antimicrobial resistance and expanding clinical indications.

• Competitive Landscape: Merck’s Cubicin remains dominant, yet biosimilars are gaining traction, reducing prices and expanding access, especially in emerging markets.

• Pricing Trends: Prices have declined due to biosimilar entry but remain high compared to traditional antibiotics, impacting formulary decisions.

• Regulatory Developments: Patent expirations in the late 2020s open opportunities for biosimilars and generic competitors, influencing future revenue streams.

• Innovation Opportunities: Focus areas include developing oral formulations, combination therapies, and personalized dosing to enhance market share and patient outcomes.

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FAQs

1. What are the primary indications for daptomycin in 0.9% Sodium Chloride?
Daptomycin is chiefly indicated for complicated skin and soft tissue infections, bacteremia, and right-sided infective endocarditis caused by Gram-positive bacteria, including MRSA and VRE.

2. How does the market for daptomycin compare with other Gram-positive antibiotics?
Daptomycin commands a significant share owing to its efficacy against resistant strains. It faces competition from vancomycin and linezolid, often being chosen for resistant infections due to its favorable pharmacokinetics and safety profile.

3. What is the impact of biosimilars on daptomycin's market trajectory?
Biosimilars threaten brand-name dominance by offering lower prices and increased accessibility, which can lead to volume growth but reduce revenue per unit for patent holders.

4. Are there new formulations or indications on the horizon?
Yes. Research into orally bioavailable daptomycin derivatives and broader indications such as pneumonia and prosthetic joint infections is ongoing, with some projected to enter trials within the next few years.

5. How might antimicrobial stewardship influence the use of daptomycin?
Enhanced stewardship programs may restrict broad use of potent antibiotics like daptomycin to preserve efficacy, potentially tempering growth but improving long-term sustainability.

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References

[1] World Health Organization. (2022). Antimicrobial Resistance: Global Report on Surveillance.
[2] IMS Institute for Healthcare Informatics. (2020). The Impact of Biosimilars in Oncology and Infectious Diseases.
[3] U.S. Food & Drug Administration. (2021). Daptomycin (Cubicin) Label.
[4] European Medicines Agency. (2022). Summary of Product Characteristics for Daptomycin.
[5] GlobalData. (2022). Infectious Disease Market Outlook.