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

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

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
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)
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)

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	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
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.

Development of Daptomycin in 0.9% Sodium Chloride: Market Dynamics, Investment Outlook, and Financial Trajectory

Last updated: February 3, 2026

---

Executive Summary

Daptomycin, a cyclic lipopeptide antibiotic, is primarily used against Gram-positive infections, including complicated skin infections and bacteremia. Its formulation in 0.9% sodium chloride (normal saline) is the standard infusion method for intravenous delivery. The drug’s market is characterized by increasing prevalence of resistant bacterial strains, expanding indications, and associated unmet medical needs driving future growth. Industry analyses project a compound annual growth rate (CAGR) of approximately 6-8% over the next five years, with revenues expected to reach USD 1.5-2 billion globally by 2027. This report assesses the investment opportunities, market dynamics, competitive landscape, regulatory considerations, and financial outlook for daptomycin in its saline formulation.

---

1. Market Overview

Parameter	Details
Current Market Size (2022)	USD 870 million[1]
Projected Market Size (2027)	USD 1.5–2.0 billion
CAGR (2022–2027)	6%–8%
Key Indications	Complex skin and soft tissue infections, bacteremia, endocarditis
Approval Status	Approved in US, Europe, Japan, and other regions

2. Market Drivers

• Rising Antimicrobial Resistance (AMR): The increasing incidence of Vancomycin-resistant Enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA) strain resurgence expands daptomycin use[2].
• Expanding Clinical Indications: Emerging evidence supports use in infective endocarditis and osteomyelitis, broadening demand.
• Limited Alternative Therapies: Resistance and side-effect profiles of other antibiotics position daptomycin as a preferred option.
• Growth in Healthcare Infrastructure: Rising hospital admissions globally, especially in emerging markets, stimulate demand for IV antibiotics.

3. Competitive Landscape

Company	Key Products	Market Share (2022)	Strengths/Weaknesses
Merck	Daptomycin (Cubicin)	~55%	Market leader, strong global distribution
Other	Off-label generic formulations	~15%	Price-sensitive, less clinical support
Emerging Players	Innovative formulations, biosimilars	Remaining	Competitive pressure, potential market entry

Note: The dominance of Merck’s Cubicin (approved in the US since 2003) remains unchallenged but generic competition and biosimilars are emerging.

4. Regulatory and Patent Landscape

Aspect	Details
Patent Status	Patent expired in several jurisdictions (post-2013), increasing generic entry threat
Regulatory Approvals	Approved by FDA (2003), EMA (2004)
Upcoming Developments	Orphan drug status grants in selected regions; new combination therapies in development

5. Investment Considerations

Aspect	Implication
Market Growth Potential	High, driven by resistance trends and expanding use-cases
Patent and Exclusivity Risks	Patent expiry (~2013) has led to patent cliff; generics expected to dominate soon
R&D Pipeline	Limited innovative formulations; focus on biosimilars and extended-release versions
Pricing Strategies	Price erosion anticipated; volume-based growth required

---

6. Financial Trajectory Analysis

Parameter	2022	2023	2024–2027 (Forecast)
Global Sales (USD)	870M	930M	1.5–2.0B
Growth Rate	—	6.9%	6–8% CAGR
Market Penetration	Established	Increasing in emerging markets	Accelerated with expanded indications
R&D and Marketing Spend	~20% of revenues	Steady increase	Maintains at 15–20% for innovation; focus on biosimilars

Assumptions: Sustained growth assumes incremental approval of expanded indications, stable resistance patterns, and moderate pricing erosion.

---

7. Key Challenges and Risks

• Generic Competition: Patent expirations intensify price competition.
• Resistance Development: Potential emergence of daptomycin-resistant strains could impact efficacy.
• Regulatory Changes: Variations in approval standards and reimbursement policies.
• Market Saturation: Mature markets could see slowed growth due to limited new indications.

---

8. Comparative Case Analysis

Drug	Indications	Market Size (2022)	Growth Outlook	Patent Status	Next-Gen Developments
Daptomycin	Gram-positive infections	USD 870M	6–8% CAGR	Patent expired	Biosimilars, combination therapy
Dalbavancin	Gram-positive infections	USD 350M	7% CAGR	Patent protected until 2027	Extended dosing schedules
Oritavancin	Similar	USD 200M	7.5% CAGR	Patent protected	New delivery form

---

9. Market Entry and Expansion Strategies

Strategy	Details	Potential Impact
Pipeline Innovation	Focus on biosimilars, extended-release formulations	Market share retention, price competitiveness
Geographic Expansion	Target emerging markets (Asia-Pacific, Latin America)	Volume growth; adaptation to local regulations
Combination Therapy Development	Synergistic formulations with other antibiotics	Address resistance challenges
Pricing Optimization	Tiered pricing, value-based pricing	Maintain margins amid generic competition

---

10. Key Performance Metrics and Investment Metrics

Metric	Value/Projection	Source/Notes
Market CAGR (2022–2027)	6–8%	Industry reports[1]
Estimated 2027 Revenue	USD 1.5–2.0 billion	Market projection
Profit Margin (2022)	~35%	Merck annual reports[3]
R&D Investment (2023–2027)	Up to USD 200M/year	Industry standard, focus on biosimilars

---

Conclusion: Investment Outlook

Daptomycin in 0.9% sodium chloride injection remains a strategic asset driven by the increasing burden of resistant Gram-positive infections. While facing patent expirations, the drug’s entrenched market position, expanding indications, and the increasing prevalence of infections resistant to other antibiotics support sustained growth. However, the landscape's competitive nature and pricing pressures necessitate continuous innovation, pipeline development, and geographic expansion to preserve market share and optimize profitability.

---

Key Takeaways

1. Robust Growth: Projected for 6–8% annually through 2027, driven by resistant infections and expandind indications.
2. Market Maturity and Competition: Patent expirations pose risks; biosimilars and generics threaten pricing power.
3. Strategic Opportunities: Focus on biosimilar development, geographic expansion, and combination therapies to sustain revenue.
4. Regulatory Considerations: Vigilance required regarding approval processes, regional policies, and resistance monitoring.
5. Financial Stability: Currently solid profit margins with potential pressure; R&D investments essential for long-term relevance.

---

FAQs

Q1: How will antimicrobial resistance impact daptomycin’s market in the next five years?
A: Increasing resistance could limit drug efficacy, prompting the need for novel formulations or combination therapies. Conversely, the rise of resistant strains enhances demand in current indications, balancing the effect.

Q2: What are the prospects for biosimilars affecting daptomycin’s revenue?
A: Patent expirations create opportunities for biosimilar entrants, which are expected to capture significant market share, leading to price reductions but also widened access.

Q3: How significant are regulatory hurdles for new applications of daptomycin?
A: Regulatory agencies require robust clinical evidence for new indications. Approval timelines can vary but generally present moderate hurdles for reformulation or expanded use.

Q4: Which emerging markets present the most lucrative opportunities?
A: Countries with rising healthcare infrastructure and high infectious disease burdens, such as China, India, Brazil, and Southeast Asia, offer high-growth potential.

Q5: What is the outlook for R&D investments in daptomycin-related innovations?
A: Continued R&D is necessary to develop next-generation formulations, biosimilars, and combination therapies to maintain competitive advantage amid patent expirations.

---

References

1. [1] Global Market Insights, "Antibiotics Market Size by Product (Penicillins, Cephalosporins, Monobactams, Carbapenems, Others), Application, Region, Growth Analysis," 2022.
2. [2] World Health Organization, "Antimicrobial resistance," 2022.
3. [3] Merck Annual Report, 2022.

(Note: All figures and projections are estimates derived from industry reports and public data as of 2022–2023; actual market metrics may vary.)