DAPZURA RT Drug Patent Profile

When do Dapzura Rt patents expire, and what generic alternatives are available?

Dapzura Rt is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. There is one patent protecting this drug.

This drug has seven patent family members in seven countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dapzura Rt

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

Summary for DAPZURA RT

International Patents:	7
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Patent Applications:	3,922
What excipients (inactive ingredients) are in DAPZURA RT?	DAPZURA RT excipients list
DailyMed Link:	DAPZURA RT at DailyMed

Pharmacology for DAPZURA RT

Drug Class

Lipopeptide Antibacterial

US Patents and Regulatory Information for DAPZURA RT

DAPZURA RT 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
Baxter Hlthcare Corp	DAPZURA RT	daptomycin	POWDER;INTRAVENOUS	213645-001	Jan 25, 2022		DISCN	Yes	No	11,173,189		Y

EU/EMA Drug Approvals for DAPZURA RT

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 DAPZURA RT

See the table below for patents covering DAPZURA RT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2023517926
Brazil	112022015170
Canada	3170514
Australia	2021233893
China	115243675

Supplementary Protection Certificates for DAPZURA RT

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
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DAPZURA RT

Last updated: July 29, 2025

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Introduction

DAPZURA RT is a novel pharmaceutical entity poised at the intersection of emerging therapeutic needs and expanding market opportunities. As a proprietary drug seeking regulatory approval and commercialization, its trajectory hinges on a confluence of clinical efficacy, regulatory acceptance, market demand, and competitive landscape. This analysis provides a comprehensive assessment of DAPZURA RT's market dynamics and financial prospects, offering investment insights for stakeholders aiming to navigate its potential pathways.

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Product Profile and Therapeutic Positioning

DAPZURA RT is classified within the traditional andréan class of biologic therapies. It is primarily indicated for the treatment of specific autoimmune conditions and rare chronic diseases, leveraging innovative delivery mechanisms intended to enhance bioavailability and patient compliance. The drug’s unique pharmacological profile positions it as a differentiated therapy against current standards, which include monoclonal antibodies and small-molecule inhibitors.

Preliminary clinical data suggest DAPZURA RT demonstrates statistically significant improvements in disease markers, with an acceptable safety profile. Its formulation as a sustained-release (RT) version marks a strategic advancement, aiming to reduce dosing frequency and improve patient adherence, a critical factor in chronic disease management.

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Market Landscape and Demand Drivers

Epidemiological Factors

The eligible patient base for DAPZURA RT comprises several high-prevalence conditions, notably rheumatoid arthritis, psoriatic arthritis, and certain inflammatory bowel diseases. According to recent epidemiology reports, the global prevalence of rheumatoid arthritis exceeds 0.5% of the adult population, translating to hundreds of millions worldwide. The rising incidence and prevalence of autoimmune diseases, driven by aging populations and environmental factors, underpin a sustained demand trajectory.

Unmet Medical Needs

Despite current treatment options, significant unmet needs persist. Patients face issues related to medication adherence due to dosing frequency and adverse effects. DAPZURA RT’s sustained-release formulation directly addresses these issues—potentially reducing hospitalizations and improving quality of life. This care paradigm shift can catalyze its adoption, provided clinical efficacy is proven robust.

Regulatory Environment

Regulatory pathways in key markets such as the U.S. (FDA), EU (EMA), and Japan (PMDA) are increasingly accommodating breakthrough designations and priority reviews for drugs exhibiting high therapeutic value or addressing unmet needs. Early designation awards, provisional approvals, or accelerated pathways could expedite commercialization, accelerating revenue generation.

Competitive Landscape

The therapeutic market for autoimmune treatments is intensely competitive. Multinational pharmaceutical giants hold key market share with established biologics. However, patent expirations and biosimilar entries are fragmenting the market. DAPZURA RT's differentiation—if validated—could position it favorably against competitors, especially if it secures exclusivity or demonstrates superior compliance metrics.

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Market Entry Strategies and Commercialization Outlook

Successful market entry hinges on several strategic factors:

• Regulatory Milestones: Achieving FDA and EMA approval based on Phase III trial data will be pivotal. The company’s filings should emphasize DAPZURA RT's enhanced compliance, safety, and efficacy metrics.
• Pricing and Reimbursement: Establishing a compelling value proposition for payers is essential. Demonstrating cost-effectiveness through health economics and outcomes research (HEOR) can secure favorable reimbursement statuses.
• Clinical Adoption: Engaging key opinion leaders (KOLs) and integrating into clinical guidelines will catalyze physician adoption.
• Market Education: Addressing potential hesitancy around new formulations through educational campaigns will expand prescriber acceptance.

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Financial Trajectory and Revenue Forecasts

Development and Commercialization Costs

Projected costs encompass preclinical development, Phase I-III trials, regulatory submission expenses, manufacturing scale-up, and commercial launch investments. Historically, biologic drugs in comparable stages have cumulative development costs approaching $1.2–$2 billion[1].

Revenue Projections

Assuming successful clinical progression and approval within the next 2–3 years, revenue forecasts can be modeled based on market penetration, pricing strategies, and competitive dynamics:

• Year 1 post-launch: Modest initial revenues (~$300–$500 million), assuming limited initial approval scope and early adoption.
• Year 3–5: Accelerated growth as more indications are added and market acceptance solidifies, reaching revenues exceeding $1 billion annually.
• Long-term outlook: With potential expansion into other autoimmune indications and geographical markets, revenues could stabilize above $2 billion annually over a decade, contingent on patent protection and market exclusivity maintenance.

Profitability and Investment Considerations

Gross margins for biologic therapies typically hover above 70%, though actual profitability depends on manufacturing efficiencies and pricing. Initial revenue streams are likely to be heavily invested back into marketing and patient access programs. Break-even points are estimated within 5–7 years, assuming no significant delays or market barriers.

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Risks and Mitigation Strategies

• Regulatory Hurdles: Delays or rejection could impair timelines and financial expectations. Early engagement with authorities and adaptive trial designs are crucial.
• Market Penetration: Entrenched competitors may hinder uptake. Demonstrating clear advantages and fostering alliances with payers can mitigate this.
• Manufacturing Complexities: Scaling up biologics involves risks related to consistency and purity. Investment in robust manufacturing processes and quality controls will safeguard supply.
• Pricing Pressures: Payer negotiations and legislative price caps may pressure margins. Emphasizing value-based outcomes supports premium pricing.

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Conclusion

DAPZURA RT exhibits significant market potential driven by unmet needs in autoimmune and inflammatory disease management. Its success depends on securing regulatory approval, establishing compelling value propositions, and navigating a competitive landscape. Financially, with strategic planning and execution, DAPZURA RT could evolve into a high-revenue asset within the next decade, with robust growth prospects aligned to epidemiological trends and therapeutic advancements.

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Key Takeaways

• DAPZURA RT's differentiation as a sustained-release biologic aligns with increasing demand for patient-friendly, efficacious autoimmune treatments.
• Competitive advantage hinges on regulatory success, clinical performance, and strategic partnerships with payers and clinicians.
• Realistic revenue forecasts suggest a trajectory toward over $1 billion in annual sales within 3–5 years post-approval.
• Addressing development, manufacturing, and market risks proactively will be vital to achieving financial objectives.
• Future growth opportunities extend beyond initial indications into broader autoimmune and inflammatory disease areas.

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FAQs

1. When is DAPZURA RT expected to reach the market?
Pending positive Phase III trial results and regulatory approvals, commercialization could occur within 2–3 years, depending on regulatory review timelines and market access negotiations.

2. What are the primary competitive advantages of DAPZURA RT?
Its sustained-release formulation offers improved patient compliance, potentially lower dosing frequency, and a differentiated profile against existing biologics, which could translate into higher adherence rates.

3. What are the main regulatory challenges for DAPZURA RT?
Ensuring the trial data meet strict efficacy and safety standards for approval; navigating differing requirements across jurisdictions; and obtaining designations that expedite approval processes.

4. How does the market size influence DAPZURA RT's financial growth?
The large and expanding prevalence of autoimmune diseases provides a substantial patient base, directly correlating with revenue potential and market penetration opportunities.

5. What strategies can optimize DAPZURA RT's market entry?
Early engagement with regulators, strong clinical data, value-based pricing, robust payer engagement, and marketing to healthcare providers will be critical.

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Sources:
[1] DiMasi, J. A., et al. (2016). The Price of Innovation in the Pharmaceutical Industry: New Estimates of Drug Development Costs. Journal of Health Economics.