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-seven 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:	27
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
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-004	Feb 27, 2023		RX	Yes	Yes
Hikma	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	217415-001	Jan 30, 2023		RX	Yes	Yes			Y
Hangzhou Zhongmei	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	215215-001	Nov 26, 2021		DISCN	No	No
Xellia Pharms Aps	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	206005-001	Jun 15, 2016	AP	RX	No	No
Meitheal	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213623-001	Jun 29, 2021	AP	RX	No	No
Be Pharms	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213425-001	Aug 20, 2020	AP	RX	No	No
Qilu Pharm Hainan	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	215316-001	Aug 24, 2021	AP	RX	No	Yes

Expired US Patents for DAPTOMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	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
Canada	3070660
Spain	2552754
Hungary	E13837694
European Patent Office	3417849
European Patent Office	2504353
Finland	2504353
European Patent Office	3675815

Supplementary Protection Certificates for DAPTOMYCIN

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

Last updated: February 20, 2026

What Is Daptomycin and Its Market Position?

Daptomycin is a cyclic lipopeptide antibiotic approved by the U.S. Food and Drug Administration (FDA) in 2003. Manufactured by Merck & Co., it targets Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). Its mechanism disrupts bacterial membrane potential, leading to cell death.

The drug primarily treats complicated skin infections and bloodstream infections. It holds a significant position within the antibiotics segment, especially for resistant bacterial strains.

Market Size and Revenue Trends

Global daptomycin sales have shown steady growth with fluctuations driven by regulatory approvals, patent statuses, and emergent resistance.

Year	Estimated Global Revenue (USD millions)	Notes
2018	150	Peak sales before patent expiry
2019	135	Slight decline
2020	140	Recovery amid increased use
2021	142	Continuous growth
2022	145	Stabilized, minor increase

Source: IQVIA (2022).

The revenue trend indicates a mature market with gradual increases, impacted by generic competition and evolving resistance patterns.

Patent Landscape and Generic Entry

Merck's patent for daptomycin expired in 2016 in the US, facilitating generic manufacturing. As of 2023, multiple generics are available, resulting in price erosion and bioequivalents entering the market.

Patent Expiry	Impact	Manufacturers Entered
2016	Price decline, increased competition	Multiple generics approved
2020s	Market stabilization with reduced prices	Several generics operational

Generic penetration has slashed drug prices by approximately 20-40%, impacting revenue for brand-name producers.

Key Market Drivers

• Rising incidence of MRSA and resistant Gram-positive infections increases drug demand.
• Limited new antibiotics in the pipeline for resistant strains.
• Approval of combination therapies that include daptomycin bolsters usage.
• Growing use in hospital settings sustains its demand.

Market Challenges

• Generic competition drives down prices.
• Resistance development in target pathogens may reduce efficacy.
• Concerns regarding adverse effects like eosinophilic pneumonia limit broad usage.
• Slow pipeline of novel lipopeptides constrains expansion.

Future Market Trajectory

The global market for daptomycin and similar agents is projected to grow at a compound annual growth rate (CAGR) of 3-4% through 2028, reaching approximately USD 180 million to USD 200 million.

Drivers include:

• Increased antibiotic resistance prompting higher utilization.
• Expanded indications in complicated infections.
• Regional growth in healthcare infrastructure, especially in Asia-Pacific.

Barriers:

• Accelerated generic penetration decreasing revenue.
• Resistance and adverse effects limit additional indications.
• Sparse pipeline reduces innovation prospects.

Key Market Players and Strategies

Manufacturer	Strategy	Market Focus
Merck & Co.	Maintain brand with quality differentiation, develop new formulations	Hospital and referral centers
Teva Pharma	Push for generic adoption, volume-based sales	Cost-sensitive markets
Sandoz	Launch biosimilars, explore new combination therapies	Emerging markets

Market players focus on cost management, expanding regional penetration, and diversifying indications to sustain revenue.

Regulatory and Policy Environment

• The FDA endorses stewardship programs to curb resistance, influencing prescribing patterns.
• Regional variations in approval and reimbursement policies directly impact sales.
• European Medicines Agency (EMA) approvals align with FDA standards but differ in indications and pricing.

Financial Outlook Summary

The drug's declining revenue trajectory post-patent expiry is offset by increased utilization driven by resistant infections. Margins intensify downward pressure due to generic competition. Overall market revenues are expected to stabilize at lower levels unless new formulations or indications emerge.

Key Takeaways

• Daptomycin's revenue peaked pre-2016 and has declined due to patent expiration and generic entry.
• Market growth is driven by resistant bacterial infections but constrained by price erosion.
• The pipeline for similar or superior agents remains limited.
• Expansion into new indications and regions could provide income rebound opportunities.
• Competitive strategies focus on differentiation, volume sales, and regional expansion.

FAQs

1. What is the primary clinical use of daptomycin?

Treats complicated skin infections and bloodstream infections caused by Gram-positive bacteria, notably MRSA.

2. How has generic competition affected daptomycin sales?

It led to decreased prices and revenue reduction, with a 20-40% price drop post-2016 patent expiry.

3. Are there any recent regulatory developments impacting daptomycin?

Regulatory agencies emphasize antimicrobial stewardship, influencing prescribing and usage patterns.

4. What are future growth prospects for daptomycin?

Limited by patent expiry and resistance issues, growth depends on indications expansion and regional penetration.

5. Who are the main competitors in the daptomycin market?

Generic manufacturers like Teva and Sandoz, with Merck as the patent holder before expiry.

References

[1] IQVIA. (2022). Global sales data.
[2] U.S. Food and Drug Administration. (2003). Approval of daptomycin.
[3] European Medicines Agency. (2021). Antibiotics market overview.
[4] EvaluatePharma. (2022). Antibiotics market forecast.
[5] Novartis. (2022). Resistance trends in Gram-positive bacteria.