DAPTOMYCIN - Generic Drug Details

What are the generic drug sources for daptomycin and what is the scope of freedom to operate?

Daptomycin is the generic ingredient in five branded drugs marketed by Cubist Pharms Llc, Accord Hlthcare, Aspiro, Be Pharms, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hangzhou Zhongmei, Hengrui Pharma, Hikma, Hisun Pharm Hangzhou, Hospira, Maia Pharms Inc, Meitheal, Mylan, Mylan Labs Ltd, Qilu Pharm Hainan, Sagent Pharms Inc, Teva Pharms Usa, Xellia Pharms Aps, and Baxter Hlthcare Corp, and is included in thirty-two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Daptomycin has ninety-seven patent family members in thirty-eight countries.

There are ten drug master file entries for daptomycin. Twenty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for DAPTOMYCIN

International Patents:	97
US Patents:	7
Tradenames:	5
Applicants:	23
NDAs:	32
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	94
Drug Prices:	Drug price trends for DAPTOMYCIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAPTOMYCIN
What excipients (inactive ingredients) are in DAPTOMYCIN?	DAPTOMYCIN excipients list
DailyMed Link:	DAPTOMYCIN at DailyMed

See drug prices for DAPTOMYCIN

Recent Clinical Trials for DAPTOMYCIN

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
University of Melbourne	PHASE4
The Peter Doherty Institute for Infection and Immunity	PHASE4

See all DAPTOMYCIN clinical trials

Generic filers with tentative approvals for DAPTOMYCIN

Applicant	Application No.	Strength	Dosage Form
		350MG/VIAL	POWDER;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DAPTOMYCIN

Drug Class

Lipopeptide Antibacterial

Medical Subject Heading (MeSH) Categories for DAPTOMYCIN

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for DAPTOMYCIN

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DAPTOMYCIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUBICIN RF	For Injection	daptomycin	500 mg/vial	021572	1	2008-11-19

US Patents and Regulatory Information for DAPTOMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspiro	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	216445-001	Dec 23, 2022	AP	RX	No	No
Hikma	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	217415-002	Jan 30, 2023		RX	Yes	Yes			Y
Mylan	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213966-001	Aug 7, 2023	AP	RX	No	No

Expired US Patents for DAPTOMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003

EU/EMA Drug Approvals for DAPTOMYCIN

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

Country	Patent Number	Title	Estimated Expiration
Australia	2018217322	Daptomycin formulations and uses thereof
Mexico	2020001885
Ecuador	SP12011939

Supplementary Protection Certificates for DAPTOMYCIN

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

Market Dynamics and Financial Trajectory for Daptomycin

Last updated: September 19, 2025

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Introduction

Daptomycin, a cyclic lipopeptide antibiotic developed by Cubist Pharmaceuticals (later acquired by Merck & Co.), has established itself as a critical agent in combating serious Gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). As antibiotic resistance escalates globally, the demand and market potential for daptomycin are poised for substantial shifts. This analysis delineates the current market landscape, growth drivers, competitive environment, regulatory factors, and future financial trajectories for daptomycin.

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Market Landscape and Therapeutic Profile

Daptomycin is primarily indicated for complicated skin and soft tissue infections (cSSTIs), bacteremia, and right-sided infective endocarditis caused by susceptible Gram-positive pathogens[1]. Its efficacy against resistant strains positions it as a vital alternative amid escalating antimicrobial resistance (AMR). Currently, the drug’s global market size exceeds USD 1.2 billion (as of 2022), driven by increased prevalence of resistant infections and favorable clinical reports.

The drug’s formulation as a once-daily infusion offers advantages over traditional therapies, further consolidating its market share. Notably, in developed markets such as North America and Europe, daptomycin maintains dominance for severe infections, with growth opportunities emerging in the Asia-Pacific region, driven by expanding healthcare infrastructure and rising antimicrobial resistance[2].

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Key Market Drivers

1. Rising Antimicrobial Resistance (AMR): The increasing prevalence of MRSA, VRE, and other resistant Gram-positive strains necessitates the use of advanced antibiotics like daptomycin. The CDC estimates over 119,000 MRSA infections annually in the U.S. alone, underscoring the antibiotic’s importance[3].

2. Limited Competition and Patent Lifecycle: While generics are entering the market, patent protections (original patent expiry around 2018-2019) provided a temporary monopoly, buoying revenue streams. Continued patent protections or formulations, such as liposomal delivery systems, may prolong market exclusivity.

3. Clinical Preference and Guidelines: Growing incorporation into treatment guidelines such as those from the Infectious Diseases Society of America (IDSA) sustains demand, especially for hard-to-treat infections[4].

4. Increasing Global Healthcare Spending: Rising healthcare investment, particularly in emerging economies, is supporting expansion of advanced antibiotic therapies.

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Market Challenges and Competitive Landscape

Despite its strengths, daptomycin faces competitive pressures:

• Emergence of Newer Agents: Novel antibiotics targeting resistant Gram-positive bacteria, such as oritavancin, dalbavancin, and televancin, offer alternative treatment options with less frequent dosing and enhanced activity[5].

• Generic Competition: The expiration of patents has led to an influx of generic versions, exerting pricing pressures. While generics expand access, they constrict profit margins for branded manufacturers.

• Safety Concerns & Resistance Development: Though generally well-tolerated, reports of creatine phosphokinase elevation and rare cases of resistance pose limitations[6]. Continuous surveillance and maintenance of efficacy are essential.

• Regulatory and Reimbursement Hurdles: Variability in regulatory frameworks across regions impacts market penetration. Reimbursement policies influence prescribing behaviors and profitability.

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Regulatory and Patent Considerations

Regulatory pathways for daptomycin remain robust, with approvals granted by the FDA, EMA, and other authorities. Patent expirations in the late 2010s catalyzed the entry of generics, impacting pricing strategies.

Innovative formulations or combination therapies could extend exclusivity. For instance, investigational liposomal formulations aim to improve tissue targeting and reduce toxicity, potentially creating new patent opportunities[7].

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Financial Trajectory and Future Outlook

Current Revenue Streams

In 2022, Merck's daptomycin revenues surpassed USD 450 million, contributing significantly to its infectious disease portfolio. The U.S. remains the largest market, accounting for roughly 50%, driven by high MRSA prevalence and healthcare infrastructure[8].

Growth Opportunities

• Emerging Markets Expansion: Growing healthcare spending in Asia-Pacific and Latin America presents avenues for market penetration. Regulatory approvals and pricing strategies tailored for these regions are essential.

• Line Extensions and Formulation Innovations: Development of oral formulations (for outpatient settings), liposomal delivery systems, and combination therapies could open new revenue streams.

• Strategic Collaborations and Licensing: Partnerships with regional pharma entities facilitate faster market entry and localized manufacturing.

Projected Trajectory (2023–2030)

Analysts project a compound annual growth rate (CAGR) of approximately 4-6% for daptomycin over the next decade, influenced by increasing AMR, expanding indications, and market diversification. The advent of resistance to current therapies and the development of enhanced formulations could further accelerate growth, potentially reaching USD 1.5 billion by 2030.

However, profit margins may face erosion due to patent expirations, regulatory costs, and generic competition. Strategic investment in innovation and geographic expansion remains vital for sustaining financial health.

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Regulatory and Development Outlook

Ongoing research aims to develop next-generation daptomycin derivatives with improved pharmacokinetic profiles and activity spectrum. Additionally, regulatory agencies are increasingly emphasizing real-world evidence to support label expansions, potentially broadening market access.

Incentivized by government initiatives to combat AMR, accelerated approval pathways and public-private collaborations could propel development timelines.

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Conclusion

Daptomycin remains a pivotal asset in the antimicrobial arsenal against resistant Gram-positive bacterial infections. Its market dynamics are characterized by robust growth driven by global antimicrobial resistance patterns, clinical guideline endorsements, and strategic innovation. While patent expirations challenge profitability, opportunities in emerging markets, formulation advancements, and combination therapies offer pathways for sustained or increased revenue.

Long-term success hinges on continued innovation, strategic patent management, and adaptation to evolving regulatory and competitive landscapes. As antimicrobial resistance underscores the urgent need for effective therapeutics, daptomycin’s trajectory appears promising, with potential to significantly expand its market presence and financial performance.

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Key Takeaways

• The global market for daptomycin exceeds USD 1.2 billion, with steady growth expected over the next decade.
• Rising prevalence of resistant Gram-positive infections, especially MRSA and VRE, sustains demand.
• Patent expiration has increased generic competition, pressuring prices and margins; innovation remains crucial.
• Expansion into emerging markets and development of novel formulations can unlock new revenue streams.
• Continuous surveillance and resistance management are vital for maintaining clinical efficacy and market relevance.

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FAQs

1. What are the main indications for daptomycin?
Daptomycin is indicated for complicated skin and soft tissue infections, bacteremia, and right-sided infective endocarditis caused by susceptible Gram-positive pathogens, including MRSA and VRE.

2. How does antimicrobial resistance influence daptomycin's market?
As resistance to traditional antibiotics escalates, clinicians increasingly turn to daptomycin as a potent alternative, driving demand and market growth.

3. What is the impact of patent expirations on daptomycin’s market?
Patent expirations have introduced generic competitors, leading to price declines and reduced profit margins for branded manufacturers; however, they also broaden access.

4. Are there ongoing developments to extend daptomycin’s lifecycle?
Yes, research into liposomal formulations, combination therapies, and next-generation derivatives aim to improve efficacy and extend patent protections.

5. What challenges could impede future growth of daptomycin?
Potential challenges include emerging resistance, pricing pressures from generics, regulatory hurdles, and competition from newer antibiotics.

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References

1. [1]CDC, "Antibiotic Resistance Threats in the United States," 2019.
2. [2]MarketResearch.com, "Global Antibiotics Market," 2022.
3. [3]CDC, "MRSA Surveillance Report," 2021.
4. [4]IDSA Clinical Practice Guidelines for MRSA, 2014.
5. [5]Barbour, A. et al., "Emerging Gram-Positive Antibiotics," Antimicrobial Agents, 2021.
6. [6]Kumar, A. et al., "Safety Profile of Daptomycin," Infectious Disease Reports, 2020.
7. [7]Liposomal Antibiotics Review, Journal of Drug Delivery Science and Technology, 2022.
8. [8]Merck Annual Report 2022.