Daptomycin - Generic Drug Details

What are the generic sources for daptomycin and what is the scope of patent protection?

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-six 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:	26
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	94
Patent Applications:	4,355
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
The Peter Doherty Institute for Infection and Immunity	PHASE4
Todd C. Lee MD MPH FIDSA	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
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003		DISCN	Yes	No
Mylan	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213966-001	Aug 7, 2023	AP	RX	No	No
Xellia Pharms Aps	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	206005-001	Jun 15, 2016	AP	RX	No	No
Hisun Pharm Hangzhou	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	212250-001	Apr 21, 2021	AP	RX	No	No
Dr Reddys	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	208375-001	May 1, 2019	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	021572-001	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	021572-001	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
Australia	2013316779
Australia	2018217322
Brazil	112015005400
Canada	2884484
Chile	2015000608

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	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	SZ 22/2006	Austria		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.

Last updated: June 23, 2026

Daptomycin Market Dynamics and Financial Trajectory (US and Major International Markets)

Daptomycin revenue has shifted from broad inpatient use toward tighter, guideline-driven positioning in skin/skin-structure infections and bloodstream infections, with added tailwinds from steeper demand for high-efficacy MRSA coverage and heightened concern about nephrotoxicity and resistance in alternatives. Financial trajectory since launch is characterized by (1) early adoption driven by MRSA, (2) mid-cycle pressure from expanding comparators and antimicrobial stewardship, (3) sustained share in settings where clinical outcomes favor daptomycin (especially bacteremia/endocarditis), and (4) risk from generic entry and payer formulary consolidation once patent and exclusivity barriers eroded.

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How has daptomycin’s revenue trajectory evolved since launch?

Broad revenue phases

Period	Market driver	Net effect on sales
Launch to early growth (mid-2000s)	IV MRSA and complicated SSTI adoption; clinicians moving away from older agents with more tolerability or resistance friction	Rapid uptake and strong branded sales
Mid-cycle expansion (late 2000s to mid-2010s)	Expanded clinical uptake in bacteremia and endocarditis; hospital formularies preferring “high confidence” MRSA coverage	Continued revenue, then normalization as penetration saturates
Mature branded era (mid-2010s to exclusivity end)	Stewardship limits broad-spectrum exposure; active comparators increase (e.g., vancomycin alternatives, ceftaroline, linezolid in selected niches)	Growth flattens; share held more by clinical fit than by fresh category expansion
Post-patent pressure (late-2010s onward)	Generic entry dynamics and PBM formulary pressure	Branded revenue compresses faster than volume growth
Current era (2020s)	Residual brand demand in complex cases; increased use of generics where procurement is tight	Steady overall antibiotic spend but with reduced brand share

What “steady demand” really means

In antibiotics, “steady demand” often reflects two forces that move in opposite directions:

1. Stable prevalence of MRSA and complicated infections in acute care.
2. Ongoing restriction of IV antibiotic exposure through stewardship, order sets, and de-escalation pathways.

Daptomycin sits in a zone where it remains clinically favored when MRSA is a concern and when the care team needs a reliable alternative to vancomycin or when tolerability in renal-compromised patients is managed through monitoring. That supports baseline utilization even as broader antibiotic budgets tighten.

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What key market dynamics drive daptomycin demand?

1) Hospital inpatient mix and infection severity

Daptomycin is primarily an inpatient IV therapy. Demand tracks:

• admissions for complicated SSTI and hospital-acquired infections
• rates of MRSA bacteremia and endocarditis
• length-of-stay and treatment duration for bacteremia/endocarditis regimens

A higher proportion of severe infections increases utilization per patient, even when the overall number of infections is flat.

2) Antimicrobial stewardship and guideline alignment

Hospital protocols increasingly emphasize:

• culture-guided narrowing
• rapid de-escalation from broad agents
• selecting narrow agents when MRSA is the suspected or confirmed pathogen

Daptomycin benefits when protocols treat MRSA bacteremia/endocarditis and complicated SSTI with a “high-efficacy” first-line or early-line option.

3) Comparator switching and safety/tolerability economics

The competitor set changes by patient and payer:

• vancomycin remains a comparator anchor, but monitoring burden and variability in AUC-based dosing affect clinician behavior
• newer agents and linezolid can be preferred for specific Gram-positive phenotypes, but cost and adverse event profiles matter
• ceftaroline and other β-lactams can gain share for specific coverage niches

Daptomycin demand therefore depends on both clinical fit and the managed-care view of total treated cost, not drug acquisition cost alone.

4) Procurement and generic substitution

Once generic procurement becomes available and stable, it typically causes:

• margin compression for branded daptomycin
• shift of formulary placement toward the lowest net-cost agent unless clinical exceptions exist

The degree of substitution depends on:

• number of available generic manufacturers
• stability of supply
• payer contracting and tendering practices

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What is the payer and formulary dynamic for daptomycin?

Formulary status tends to be “restricted” in mature markets

In the US hospital channel, restricted availability (step edits, prior authorization, or infectious disease review) is typical for high-cost hospital anti-infectives. Daptomycin often survives as a formulary option because:

• it covers MRSA reliably
• it aligns with ID input and protocol-driven use for bacteremia/endocarditis and complicated SSTI

When procurement is generic-shifted, formularies increasingly look like:

• preferred generic daptomycin
• brand daptomycin available via non-preferred status exceptions
• clinical carve-outs for specific patient risk profiles (renal status monitoring policies, prior treatment failure)

Commercial channel

Outside hospital procurement, community utilization is limited due to IV-only positioning. Thus, market size is dominated by the hospital acute-care budget rather than retail pharmacy dynamics.

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How do biosimilar and biologic dynamics apply to daptomycin?

Daptomycin is a small-molecule antibiotic, not a biologic. Biosimilar pathways do not apply. Competitive risk is instead driven by:

• generic small-molecule entry
• label expansion or narrowing through supplemental approvals for related indications
• comparative clinical practice and payer contracting

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How many patents and exclusivity layers protect daptomycin, and when do they expire?

Patent estate structure typical for daptomycin

Daptomycin’s protection historically includes a blend of:

• composition-of-matter patents for the active ingredient
• formulation/manufacturing patents (e.g., vial composition, stability, preparation steps)
• method-of-use patents for particular indications or dosing strategies

Exclusivity categories that matter

In the branded antibiotic era, exclusivity typically includes:

• regulatory exclusivity around new clinical investigations or approvals
• potential pediatric or other statutory exclusivity depending on the approval history
• patent term plus any granted patent term adjustments

Because daptomycin is now in mature-market status, most value capture has already moved into the generic substitution era, making financial trajectory primarily a “post-exclusivity erosion” story rather than ongoing exclusivity value.

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When does generic competition typically compress daptomycin pricing and margins?

Mechanism of revenue compression

Generic entry generally drives:

• faster volume share shift than price decline due to payer contracting
• loss of premium brand pricing
• margin compression even when overall antibiotic demand stays flat

Time profile

In mature branded antibiotics, brand revenue typically shows:

• a step down around initial generic launches and contracting updates
• further erosion after additional generic entrants and tenders consolidate around net cost

What stabilizes brand revenue even after generics launch

Brand can retain some share because:

• hospital preference for a known supply and product characteristics
• internal formulary preferences in specific ID protocols
• clinical exception handling where brand is used despite higher acquisition cost

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How does daptomycin performance compare against key Gram-positive alternatives financially?

Comparator map

Drug class	Typical role vs daptomycin	Financial impact pattern
Vancomycin	Core comparator for MRSA coverage	Competes strongly on perceived cost and protocol familiarity
Linezolid	Oral/IV options in select Gram-positive settings	Can displace daptomycin where oral step-down and outcomes favor linezolid
Ceftaroline	Alternative for skin infections where MRSA coverage needed	Can gain share in complicated SSTI bundles
Other newer MRSA agents	Niche or evolving guideline roles	Share shifts depend on local stewardship and cost contracts

Financial trajectory for daptomycin is therefore less about category growth and more about how it “wins protocols” for:

• MRSA bacteremia/endocarditis
• complicated SSTI in hospital settings with monitoring capacity
• cases where vancomycin dosing variability is a concern

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What is the litigation and settlement landscape impact on daptomycin revenue?

Generic entry risk tied to Paragraph IV challenges

Where ANDA filings include Paragraph IV certifications, litigation can:

• delay final approval and launch
• trigger settlements that set “launch dates” or authorized entry windows

Those legal events shape revenue by controlling:

• the timing of first generic entry
• whether multiple generics can launch immediately or sequentially

For mature products like daptomycin, the dominant revenue question becomes not “will generics enter,” but “how early and how many entrants appear.”

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What is the FDA and Orange Book status of daptomycin that affects market access?

Orange Book dynamics that matter for market forecasting

The Orange Book generally drives commercial behavior through:

• listed patents linked to approvals
• expiration dates that determine ANDA launch constraints
• exclusivity codes that create additional launch barriers

Once key Orange Book-listed patents and exclusivities expire, market access shifts quickly to low-cost procurement outcomes, and daptomycin’s branded financial trajectory typically follows.

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What formulation factors affect market competitiveness for daptomycin?

Hospital procurement and supply continuity

Formulation stability and vial characteristics influence:

• pharmacy handling workflows
• administration standardization
• stock management in inpatient settings

When generic product attributes are seen as “equivalent enough,” tendering favors the lowest-cost supplier. If differences in supply chain reliability occur, brand or certain generics can temporarily retain share.

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What commercial scenarios determine daptomycin’s next 3 to 5 year financial path?

Scenario framework

Scenario	Generic competitive intensity	Revenue impact
Baseline	Multiple generics, stable supply, continued restricted formulary use	Branded revenue continues to decline or flatten; overall category stays steady
Accelerated	Additional entrants reduce net costs faster; stronger payer step edits	Faster brand erosion; steeper margin compression
Resilient	Formularies carve out clinical exception patterns; brand used for complex cases	Branded revenue declines more slowly; generic preference still dominates total market
Shock	Supply disruptions for key generic SKUs or contracting instability	Temporary price spikes and share shifts favoring available supply

In practice, the largest determinant is the net-cost contracting environment, followed by stewardship and guideline shifts that modify which Gram-positive options are prioritized for MRSA bacteremia/endocarditis and complicated SSTI.

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Key Takeaways

• Daptomycin demand is anchored in inpatient severe Gram-positive infections, especially where MRSA coverage and clinician confidence in outcomes support IV therapy.
• Market dynamics increasingly favor procurement-driven substitution after exclusivity and patent barriers erode, causing branded revenue compression even when treated patient volumes remain stable.
• Financial trajectory is driven more by payer contracting and generic intensity than by category growth.
• The next phase of performance is dominated by how quickly additional generic entrants reduce net costs and how stewardship protocols balance daptomycin against vancomycin, linezolid, and other MRSA-active options.

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FAQs

1) What infections drive most daptomycin utilization and revenue?

Complicated skin/skin-structure infections and bloodstream infections, particularly when MRSA is implicated, are the core utilization drivers in inpatient settings.

2) Does daptomycin compete more on clinical outcomes or acquisition cost?

Both. In mature markets, payer contracting emphasizes net cost, while clinicians use clinical outcomes and protocol fit to justify exceptions or preferred selection within formularies.

3) Are there biosimilar risks for daptomycin?

No. Daptomycin is not a biologic; competition comes from small-molecule generics and related market access events.

4) How does generic entry typically change formulary placement?

Formularies usually shift from brand-preferred or restricted brand to preferred generic status, with brand retained only for exceptions and transition needs.

5) What regulatory or patent events most affect near-term sales?

The timing of Orange Book patent and exclusivity expiry and any ANDA litigation or settlement-related launch delays are the primary near-term sales levers.

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. (n.d.). Drugs@FDA: Daptomycin. U.S. Food and Drug Administration.
3. IMS Health / IQVIA. (n.d.). Antibiotics market and sales data (hospital and retail channel datasets).