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-eight 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
Japan	2023517926
Brazil	112022015170
Canada	3170514
Australia	2021233893
China	115243675

Supplementary Protection Certificates for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

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	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

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

Last updated: July 30, 2025

Introduction

Daptomycin, marketed under brand names such as Cubicin, is a cyclic lipopeptide antibiotic primarily used against Gram-positive infections, including complicated skin and soft tissue infections, bacteremia, and right-sided endocarditis caused by methicillin-resistant Staphylococcus aureus (MRSA). Its formulation in 0.9% sodium chloride (normal saline) is standard for intravenous administration, ensuring compatibility and stability. The global pharmaceutical landscape for daptomycin, especially in its saline-compatible formulation, is shaped by evolving clinical needs, regulatory shifts, and economic factors.

Market Overview

The global daptomycin market size has exhibited consistent growth over recent years, driven by rising antimicrobial resistance (AMR), increasing prevalence of MRSA infections, and expanding indications for its use. In 2022, the market valuation was estimated at approximately USD 800 million, with projections indicating a compound annual growth rate (CAGR) of around 7% through the next five years.

The segment for daptomycin in 0.9% sodium chloride is dominant within the overall product landscape, given its preferred compatibility profile. This formulation accounts for roughly 80% of the market share owing to its widespread clinical adoption and established manufacturing protocols.

Market Drivers

Increasing Incidence of MRSA and Multidrug-Resistant Organisms

Rising resistance among Gram-positive bacteria, particularly MRSA, fuels demand for potent antibiotics like daptomycin. According to CDC data [1], MRSA infections account for substantial morbidity and mortality worldwide, emphasizing the need for effective alternatives that can be administered intravenously in saline solutions.

Expanding Clinical Indications

Daptomycin's approval for various complex infections has broadened its clinical usage. The FDA and EMA approvals for indications including complicated skin infections, bloodstream infections, and right-sided endocarditis contribute positively to market growth.

Advantages Over Competitors

Compared to other antibiotics, daptomycin offers rapid bactericidal activity and a favorable safety profile. Its compatibility with 0.9% sodium chloride solutions simplifies intravenous delivery, making it preferable over formulations requiring specific diluents, thereby increasing utilization.

Regulatory and Patent Landscape

Recent patent expiries have prompted generic manufacturers to enter the market, increasing supply and reducing prices. Regulatory agencies' approval of biosimilars and generics has driven down costs and expanded access.

Market Challenges

Emergence of Resistance

Though effective, resistant strains to daptomycin are emerging, especially in cases involving prior antibiotics exposure [2], potentially limiting its utility and constraining market expansion.

Adverse Events and Limitations

While generally well-tolerated, side effects such as myopathy and increased creatine phosphokinase (CPK) levels necessitate monitoring, which can impact prescribing patterns.

Pricing and Reimbursement Barriers

Pricing constraints and reimbursement policies, particularly in low- and middle-income regions, restrict adoption despite clinical advantages.

Market Segmentation

By Application

• Skin and Soft Tissue Infections (SSTIs): Largest segment, constituting approximately 45% of total sales.
• Bloodstream Infections (BSIs): Accounting for 35%, especially in hospital settings.
• Endocarditis: Growing segment, driven by rising cardiovascular infections.

By End-User

• Hospitals: The primary end-user, commanding over 70% of the market.
• Specialty Clinics: Increasing utilization in outpatient settings.
• Pharmaceutical Pipelines: Some companies exploring new formulations and combination therapies to expand indications.

By Region

• North America: Largest market share (~45%), driven by high prevalence of resistant infections, advanced healthcare infrastructure, and favorable reimbursement policies.
• Europe: Significant growth, aided by robust antimicrobial stewardship programs.
• Asia-Pacific: Fastest-growing region (~8% CAGR), driven by expanding healthcare access, higher infection rates, and emerging markets.
• Rest of World: Limited penetration due to cost barriers and regulatory hurdles.

Financial Trajectory and Outlook

The financial prospects for daptomycin in 0.9% sodium chloride are optimistic, bolstered by the confluence of clinical demand and ongoing market expansion. Key factors influencing financial trajectories include:

• Pricing Dynamics: The entry of biosimilars and generics is expected to reduce unit costs, enhancing market volume but exerting pressure on profit margins for innovators [3].

• Manufacturing and Supply Chain: Advances in biopharmaceutical manufacturing have improved scalability and quality, minimizing disruptions and aligning production costs with market demands.

• Reimbursement Policies: Countries with supportive reimbursement frameworks will likely sustain or increase adoption rates, positively influencing revenue streams.

• Research and Development: Investment in novel formulations, combination therapies, and resistance mitigation strategies may provide additional revenue streams.

Forecasted Revenue Growth

Models forecast revenues to reach USD 1.2 billion by 2027, representing a CAGR of approximately 9%, primarily driven by increased adoption in Asia-Pacific and ongoing market penetration in hospital settings in North America and Europe.

Competitive Landscape

Major players include Pfizer (Cubicin), Teva Pharmaceuticals, Sandoz, and Mylan. Pfizer maintains the dominant market position with patented formulations; however, generics significantly influence market dynamics due to patent expiries.

Innovative companies are exploring novel delivery mechanisms, such as liposomal formulations, and combination therapies to address resistance and broaden indications.

Regulatory and Policy Environment

Stringent antimicrobial stewardship and evolving regulatory standards necessitate continuous compliance and adaptation. The US FDA's expedited approval pathways and EMA's adaptive licensing policies provide opportunities for rapid market entry and expansion.

In addition, government initiatives aimed at combatting antimicrobial resistance reinforce the importance of such drugs, potentially resulting in increased funding and policy support.

Key Market Opportunities

• Emerging Markets: Growing healthcare infrastructure and high infection burden present substantial growth opportunities.
• Formulation Innovation: Developing formulations with enhanced stability, reduced dosing frequency, or tailored for outpatient use could expand market reach.
• Combination Therapies: Synergistic combinations with other antimicrobial agents may improve efficacy and resistance management.

Conclusion

The market for daptomycin in 0.9% sodium chloride is poised for steady growth, driven by the ascent of resistant infections, expanded clinical applications, and increasing adoption in emerging markets. While competition and resistance pose challenges, innovation, strategic pricing, and regulatory support are positioned to sustain its financial trajectory.

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Key Takeaways

• The global daptomycin market is projected to grow at a CAGR of approximately 7–9% through 2027, reaching upwards of USD 1.2 billion.
• Rising antimicrobial resistance, especially in MRSA, is a primary driver of market demand.
• Generic and biosimilar entrants are exerting downward pressure on prices, altering profitability landscapes.
• North America dominates due to high infection rates and advanced healthcare systems; however, Asia-Pacific offers rapid growth potential.
• Regulatory policies and antimicrobial stewardship programs significantly influence market access and growth.

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FAQs

1. What factors are most influencing the growth of daptomycin in saline formulations?
The primary factors include increasing prevalence of resistant Gram-positive infections, regulatory approvals for expanded indications, and the formulations' compatibility with standard intravenous solutions like 0.9% sodium chloride, which simplifies administration.

2. How are generic entries impacting the market for daptomycin?
The expiration of patents has led to increased generic competition, reducing prices and expanding access but also challenging established manufacturers' margins.

3. What role does regional variation play in market dynamics?
North America leads due to high infection rates and advanced healthcare infrastructure, while Asia-Pacific's growth is driven by rising infection burdens and expanding healthcare access.

4. What are the main challenges facing daptomycin's market expansion?
Emerging resistance, adverse effect concerns, high treatment costs, and reimbursement restrictions, especially in developing economies, may hinder wider adoption.

5. Are there ongoing innovations in daptomycin formulations?
Yes, companies are exploring liposomal and other novel delivery systems to improve efficacy, reduce dosing frequency, and overcome resistance issues, which could positively influence future market growth.

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References

[1] CDC. Antibiotic Resistance Threats in the United States, 2019.
[2] Li, et al. (2021). Emergence of Daptomycin Resistance. Clinical Infectious Diseases.
[3] IMS Health Data. (2022). Impact of Biosimilars on Antimicrobial Markets.