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-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
Maia Pharms Inc	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	217630-002	Nov 21, 2024		RX	Yes	Yes
Baxter Hlthcare Corp	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	daptomycin	SOLUTION;INTRAVENOUS	213645-002	Feb 27, 2023		RX	Yes	Yes
Cubist Pharms Llc	CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572-003	Jul 6, 2016		DISCN	Yes	No			Y
Qilu Pharm Hainan	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	215316-001	Aug 24, 2021	AP	RX	No	Yes
Meitheal	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213786-001	Jun 29, 2021	AP	RX	No	No
Aspiro	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	216413-001	Sep 23, 2022	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
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	021572-001	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
Japan	2017075186
China	111093625	达托霉素制剂 (DAPTOMYCIN FORMULATIONS)
Singapore	11201506113W	DAPTOMYCIN FORMULATIONS AND USES THEREOF
Lithuania	2504353
Spain	2686331
Mexico	366122	FORMULACIONES DE DAPTOMICINA Y USOS DE LA MISMA. (DAPTOMYCIN FORMULATIONS AND USES THEREOF.)

Supplementary Protection Certificates for daptomycin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	06C0022	France		PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
1115417	SZ 22/2006	Austria		PRODUCT NAME: DAPTOMYCIN
1115417	CA 2006 00018	Denmark		PRODUCT NAME: DAPTOMYCIN
1115417	22/2006	Austria		PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119

Daptomycin: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

Daptomycin is a lipopeptide antibiotic used for serious Gram-positive infections, including complicated skin and skin structure infections (cSSSI) and bacteremia/right-sided infective endocarditis (with activity extended to off-label uses in some settings). The financial trajectory is shaped by (1) price erosion from generic entry, (2) payer and hospital formulary pressure toward lower-cost agents, (3) shifting utilization patterns driven by stewardship and safety monitoring, and (4) competition from newer Gram-positive therapies and alternative classes.

How large is daptomycin’s market and where does demand come from?

Primary use markets

Daptomycin demand concentrates in:

• cSSSI and bloodstream infections caused by susceptible Gram-positive pathogens.
• Right-sided infective endocarditis in labeled indications (and clinically adjacent treatment settings).
• Institutional hospital procurement rather than retail pharmacy pull-through.

Geography and channel

• In major developed markets, demand moves with hospital formularies and contracting, not consumer demand.
• In the US, revenue is heavily influenced by managed care contracting and the post-patent transition to generic and authorized generic supply.

Demand drivers

Core volume drivers are:

• Hospital admission patterns for serious infections
• Antibiotic stewardship protocols that determine when a high-cost agent is selected
• Clinical guidance on duration and monitoring, especially creatine phosphokinase (CPK) surveillance in risk patients (a decision point for formulary committees)

What market dynamics are dominating current pricing and volume?

1) Patent expiry and generic substitution

Daptomycin’s economics are dominated by US and EU patent expiry timelines and the speed of generic substitution after launch of lower-cost entrants. Once multiple generics gain share, list price becomes a poor proxy for net revenue, since payer contracting resets effective prices.

2) Hospital contracting and reference pricing

Hospital systems and group purchasing organizations exert pressure through:

• competitive tendering among line items
• reference pricing versus comparator antibiotics
• step-therapy practices when clinically appropriate

3) Safety and protocol standardization

Daptomycin’s use is standard in serious Gram-positive infections but depends on local protocols that address:

• CPK monitoring
• dose adjustments and discontinuation criteria
• avoidance or caution with certain co-administered agents in specific risk profiles

Where monitoring costs and staff workload rise, formulary committees can tighten usage criteria, especially for lower-acuity cases.

4) Competitive set for Gram-positive infections

Daptomycin competes against:

• Other parenteral agents used in cSSSI and bloodstream infections (including alternative Gram-positive coverage)
• Agents with different administration profiles or payer-preferred status
• Newer antibiotics and regimen strategies that can win share in specific pathogen or resistance subsets

How does the financial trajectory of daptomycin typically evolve post-patent?

The daptomycin revenue curve in most markets follows a repeatable pattern:

1. Pre-transition (branded dominance): highest margin, strong contracting position, broad formulary access.
2. Transition (first generic arrivals): accelerated price compression, volume still partially offsets price drop.
3. Mature generic phase: net price continues to fall; volume stabilizes or declines depending on stewardship and competition.
4. Late-stage (multi-source equilibrium): margins stabilize at low levels; growth is largely tied to infection incidence and minor protocol shifts.

In business terms, the trajectory depends less on “biologic growth” and more on contracting outcomes and relative economics of alternative therapies.

What are the commercial pressure points that decide revenue in daptomycin?

Net price is the critical variable

Daptomycin’s branded list pricing power typically erodes quickly once multiple generic products exist. Revenue performance becomes a function of:

• weighted average net price under payer contracts
• mix by dose and treatment duration
• share of tendered formulary positions

Use-case mix changes

Revenue can fall faster than volume if:

• case mix shifts to pathogens requiring alternative therapies
• protocols shorten or restrict daptomycin usage
• clinicians migrate to competing regimens for certain infection types

Financial outcome summary

Across major markets, the expected pattern is:

• downward net price after generic entry
• flattening or decline in branded revenue
• shift from high-margin branded economics to low-margin multi-source competition

This pattern is consistent with how anti-infective niche specialists experience post-patent commoditization in inpatient hospital markets.

Key historical and strategic milestones affecting market outcomes

Origin and brand positioning

Daptomycin is marketed as Cubicin in the US market historically. Its clinical adoption is driven by demonstrated activity in serious Gram-positive infections and institutional uptake for cSSSI and bacteremia/right-sided endocarditis.

Generic transition

Generic entry introduces:

• substantial net price compression
• procurement preference for lower-cost SKUs
• reduced differentiation versus other Gram-positive agents

Regulatory and manufacturing scale

Mature multi-source supply can support continued volume, but it also drives pricing pressure when procurement shifts to the lowest contracted price.

Where does money go: revenue vs. margin profile after commoditization?

Branded phase

• Higher net margin
• More stable net pricing due to contracting leverage and limited alternatives
• Revenue tied to volume growth and market access

Generic phase

• Margin collapses
• Revenue tracks infection incidence and contracting outcomes
• Share is determined by tender success and supply reliability

What competitors and substitution dynamics matter most?

Substitution tends to occur in two scenarios:

• Protocol-driven switching for certain infection types or severity levels
• Budget-driven switching when formulary committees set preferred agents based on total acquisition cost and administration logistics

The result is that daptomycin’s financial performance increasingly resembles a commodity antibiotic within the Gram-positive inpatient space.

Market trajectory by timeline (conceptual)

Phase	Dominant driver	Revenue shape	Pricing outcome
Branded dominance	clinical differentiation + formulary access	growth or stable	high net price
First generic entrants	competitive contracting	decline accelerated	sharp net price compression
Mature multi-source	tendering + reference pricing	stabilization or decline	low net price, limited upside
Late-stage	mix changes and stewardship	flat to down	margins constrained

Key Takeaways

• Daptomycin’s market is dominated by inpatient hospital contracting, with demand concentrated in serious Gram-positive infections.
• The financial trajectory is shaped primarily by generic substitution and net price compression, not by new patient acquisition.
• Stewardship and safety monitoring protocols can tighten or expand usage criteria, impacting volume and mix.
• In mature phases, daptomycin behaves like a low-margin multi-source product, with revenue depending on infection incidence and tender outcomes.

FAQs

1) What determines daptomycin revenue after generic entry?

Net revenue depends on weighted average net price, dose and duration mix, and share of hospital tendered formulary positions.

2) Does daptomycin face switching due to safety monitoring?

Usage is influenced by local protocols for CPK monitoring and risk management, which can affect prescribing thresholds.

3) What infection types most affect daptomycin utilization?

The largest labeled demand comes from cSSSI and bacteremia/right-sided endocarditis, with hospital practice potentially expanding or restricting indications based on stewardship.

4) Who are the substitution threats in hospital formularies?

Competitors are other parenteral Gram-positive options and newer regimen strategies that win formulary access based on cost and protocol fit.

5) Is growth still possible in a mature market?

Yes, but upside is typically limited to infection incidence trends and protocol-driven mix changes, not to branded-style price expansion.

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References

[1] Cubicin (daptomycin) prescribing information. FDA.
[2] Drugs@FDA: Cubicin (daptomycin) NDA and labeling history. U.S. Food and Drug Administration.
[3] IMS/US hospital antibiotic contracting dynamics (general market structure). Peer-reviewed and industry analyses on inpatient antibiotic procurement and formulary switching.
[4] General literature on daptomycin safety monitoring (CPK monitoring) and clinical protocols. Peer-reviewed sources.