CUBICIN Drug Patent Profile

When do Cubicin patents expire, and when can generic versions of Cubicin launch?

Cubicin is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are two patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in CUBICIN is daptomycin. There are ten drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cubicin

A generic version of CUBICIN was approved as daptomycin by TEVA PHARMS USA on March 25^th, 2016.

Summary for CUBICIN

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	40
Patent Applications:	3,922
Drug Prices:	Drug price information for CUBICIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CUBICIN
What excipients (inactive ingredients) are in CUBICIN?	CUBICIN excipients list
DailyMed Link:	CUBICIN at DailyMed

See drug prices for CUBICIN

Recent Clinical Trials for CUBICIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vancouver Island Health Authority	Phase 4
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
McGill University Health Center	Phase 4

See all CUBICIN clinical trials

US Patents and Regulatory Information for CUBICIN

CUBICIN is protected by one US patents.

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	021572-001	Sep 12, 2003		DISCN	No	No
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003		DISCN	Yes	No	8,003,673
Cubist Pharms Llc	CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572-003	Jul 6, 2016		DISCN	Yes	No	9,138,456		Y

Expired US Patents for CUBICIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	8,058,238
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003	6,852,689
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	6,852,689
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003	5,912,226
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	5,912,226

EU/EMA Drug Approvals for CUBICIN

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 CUBICIN

See the table below for patents covering CUBICIN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2940034
Serbia	57566	LIPOPEPTIDNE KOMPOZICIJE I POSTUPCI POVEZANI SA NJIMA (LIPOPEPTIDE COMPOSITIONS AND RELATED METHODS)
Japan	2002525335
Iceland	5890
Portugal	1586580

Supplementary Protection Certificates for CUBICIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1115417	300232	Netherlands		DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), VERANDERING VAN DE JURIDISCHE ENTITEIT
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
1115417	06C0022	France		PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119

CUBICIN (daptomycin): Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is CUBICIN’s commercial profile and where does it sit in the antibacterial market?

CUBICIN is the brand name for daptomycin, a cyclic lipopeptide antibiotic used for serious Gram-positive infections, including complicated skin and skin structure infections (cSSSI) and bacteremia/right-sided infective endocarditis due to Staphylococcus aureus, with restrictions and use patterns that reflect stewardship and comparative efficacy.

From a market-structure standpoint, daptomycin competes in serious Gram-positive disease where buyers evaluate:

• clinical outcomes and safety profile (including creatine phosphokinase monitoring and musculoskeletal adverse effects),
• local antibiogram fit and formulary placement,
• total cost of care (drug plus monitoring and length-of-stay impact),
• reserve-antibiotic policies that limit use after resistance or guideline changes.

CUBICIN has matured into a late-lifecycle branded antibiotic profile in the U.S. and other developed markets, with the typical trajectory driven by:

• generic entry and price compression,
• channel and formulary share shifts toward lower-cost alternatives,
• substitution dynamics inside the daptomycin class and across other Gram-positive regimens,
• periodic label updates that change prescriber eligibility and dosing uptake.

What has driven CUBICIN’s demand over time?

Across the antibacterial category, CUBICIN’s sales velocity has historically tracked four forces:

1. Guideline and protocol placement

   • Daptomycin use is governed by guideline positioning for MRSA and other resistant Gram-positive infections and by how hospitals write empiric-to-targeted therapy pathways.
   • Protocols also determine who gets rapid escalation to daptomycin and under what severity thresholds.

2. Formulary access and stewardship controls

   • Reserve antibiotic stewardship programs often restrict daptomycin to defined indications, cultures, and severity windows.
   • These controls reduce broad empiric use and narrow total accessible volume.

3. Safety, monitoring burden, and clinician adoption

   • Dosing requires monitoring practices that factor into clinician preference versus comparator agents.
   • Safety messaging influences both uptake (confidence) and discontinuation (if monitoring flags rise).

4. Pricing power loss after generic competition

   • The long-run market dynamic for branded sterile injectables is price erosion once AB-rated generics become dominant.
   • This typically compresses revenue even if unit use remains stable.

How has the IP and generic landscape affected financial trajectory?

The financial trajectory for a branded injectable like CUBICIN is shaped primarily by:

• the timing of patent expiry and loss of exclusivity,
• the depth and speed of generic competition,
• retailer and provider contracting outcomes that shift to lower WAC and AWP-driven pricing structures.

In practice, once generics establish supply and broad formulary acceptance, a branded product’s revenue often declines to:

• residual share in higher-cost contracting environments,
• remaining use among sites that maintain the brand for formulary reasons,
• inventory and buying-cycle lag effects.

CUBICIN’s late-stage profile aligns with this pattern: commercial growth is not the base case; defense is (through contract retention and clinical positioning), then erosion is once generics reach scale.

What do the available market and company data imply about CUBICIN’s financial trajectory?

Public company reporting does not track every marketed brand separately in a way that supports a clean, audited quarter-by-quarter “CUBICIN-only” financial model across all years. Still, the financial trajectory for CUBICIN can be inferred from:

• the product’s branded status and exposure to generic substitution,
• the standard post-exclusivity path for branded antibiotics,
• the known corporate reporting framework used by the original holder of CUBICIN’s commercial rights.

Key directional conclusion: CUBICIN’s financial trajectory is dominated by a shift from branded volume and price toward generic-led unit economics, with the branded P&L increasingly determined by contractual mix and any residual premium attributable to specialty purchasing constraints.

Revenue drivers vs. headwinds (commercial levers that move outcomes)

Commercial factor	Effect on CUBICIN demand	Effect on revenue
Major Gram-positive infection incidence	Stabilizes treated volume	Supports baseline units
Hospital formulary status	Drives access vs restriction	Improves or limits share
Stewardship protocols	Narrows eligible prescribing	Limits addressable volume
Safety monitoring burden	Affects clinician comfort and persistence	Influences continuation vs switch
Generic substitution after exclusivity	Reduces brand share	Compresses realized net price

What the branded-to-generic lifecycle typically does to trajectory

• Pre-exclusivity: revenue is supported by brand differentiation, procurement premiums, and contracting.
• Early post-exclusivity: revenue drops faster where formularies switch quickly and where multiple AB-rated competitors enter.
• Mature post-exclusivity: revenue stabilizes at a low branded fraction, with variability tied to contracting and case-mix severity.

How does CUBICIN compare economically inside its antibacterial spending bucket?

In serious Gram-positive infections, buyers segment spend by:

• empiric-only spend versus confirmed culture-driven spend,
• inpatient severity and expected length-of-stay,
• monitoring and administration overhead.

Daptomycin’s economic comparison is typically decided on:

• total treatment course cost (drug price plus monitoring),
• clinical outcome risk tradeoffs versus alternatives,
• local contracting and payer coverage.

Once generic daptomycin is available, the brand competes mainly on:

• tender differentiation and supply continuity commitments,
• clinical or operational preferences at certain large accounts.

This structure limits long-run price premiums, pulling CUBICIN toward reduced margins even where clinicians remain comfortable with the molecule.

What market dynamics matter most for investors considering a lifecycle antibiotic position?

For an antibiotic brand like CUBICIN, market dynamics that most directly affect the financial trajectory are:

1. Time-to-substitution and formulary mechanics

   • Uptake depends on committee cycles, P&T decisions, and procurement contract terms.

2. Generic competitor count and pricing behavior

   • More entrants and aggressive pricing increase erosion speed.

3. Guideline specificity

   • When guidelines define narrow use cases, the overall volume pool narrows, increasing competitive intensity for eligible patients.

4. Safety and administration constraints

   • Monitoring requirements shape adherence to protocols and can move volume away from a regimen if operational burden is higher.

5. Hospital contracting and distribution

   • GPO and IDN contracts can lock in switching even when prescribers prefer a brand.

What is the likely “shape” of future financial performance for CUBICIN?

A mature branded antibiotic like CUBICIN generally shows a trajectory driven by:

• declining branded share relative to generics,
• stable or slowly declining total treated volume,
• periodic variability from infection seasonality and patient acuity,
• revenue dominated by realized net price and contract mix.

Absent new exclusivity events (for example, new formulation, new controlled-release profile, or meaningful label expansion that changes standard-of-care), the dominant expected path is:

• steady erosion in revenue tied to net price and share, with possible stabilization at a residual brand base.

Key Takeaways

• CUBICIN’s market dynamics are governed by reserve-antibiotic access and stewardship constraints, which narrow eligible prescribing and stabilize a limited volume pool.
• Post-exclusivity generic substitution is the main driver of revenue compression, with branded outcomes increasingly dependent on contracting and residual share.
• Financial trajectory is best modeled as branded share erosion rather than growth, with variability from infection incidence, severity mix, and procurement cycles.
• Investor or R&D planners should treat mature antibiotic brands as contract-driven and price-sensitive assets, where protocol access and formulary timing determine upside or additional decline.

FAQs

1. Is CUBICIN primarily used for MRSA or broader Gram-positive infections?
   It is used for serious Gram-positive infections including MRSA in the labeled indications, with use guided by culture results and guideline placement.

2. What typically causes the largest revenue decline for branded antibiotics like CUBICIN?
   Generic entry and rapid formulary switching that compress realized net price and reduce branded share.

3. Do hospital stewardship programs usually expand or restrict CUBICIN usage?
   They typically restrict use to defined scenarios to preserve reserve antibiotics, narrowing prescribing eligibility.

4. What market levers most affect CUBICIN’s performance after exclusivity loss?
   Contract terms, GPO/IDN purchasing behavior, number and pricing of generic competitors, and how quickly P&T committees switch.

5. Can CUBICIN maintain revenue despite generic competition?
   It can retain residual revenue through remaining branded contracting preference and supply or operational considerations, but broad pricing power generally erodes.

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References

[1] FDA. (2019). CUBICIN (daptomycin) prescribing information. U.S. Food and Drug Administration.
[2] FDA. (2024). Daptomycin product information and regulatory history. U.S. Food and Drug Administration.
[3] EMA. (n.d.). Daptomycin-related assessment materials. European Medicines Agency.
[4] Clinical guidelines (IDSA and related stewardship guidance). (n.d.). Recommendations for Gram-positive serious infections and antibiotic stewardship. Infectious Diseases Society of America.