XACDURO (COPACKAGED) Drug Patent Profile

Which patents cover Xacduro (copackaged), and what generic alternatives are available?

Xacduro (copackaged) is a drug marketed by Entasis Therap and is included in one NDA. There are four patents protecting this drug.

This drug has eighty patent family members in forty-three countries.

The generic ingredient in XACDURO (COPACKAGED) is durlobactam sodium; durlobactam sodium; sulbactam sodium. One supplier is listed for this compound. Additional details are available on the durlobactam sodium; durlobactam sodium; sulbactam sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Xacduro (copackaged)

Xacduro (copackaged) will be eligible for patent challenges on May 23, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 23, 2033. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for XACDURO (COPACKAGED)

International Patents:	80
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XACDURO (COPACKAGED)
DailyMed Link:	XACDURO (COPACKAGED) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XACDURO (COPACKAGED)

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

216974

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for XACDURO (COPACKAGED)

XACDURO (COPACKAGED) is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	10,376,499		Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	9,309,245			Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	9,968,593		Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	9,623,014
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes

International Patents for XACDURO (COPACKAGED)

When does loss-of-exclusivity occur for XACDURO (COPACKAGED)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

European Patent Office

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XACDURO (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Malaysia	176969	HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS
Malaysia	196240	COMBINATION THERAPY FOR TREATMENT OF RESISTANT BACTERIAL INFECTIONS
Australia	2013245399	Heterobicyclic compounds as beta-lactamase inhibitors
Serbia	58429	KOMBINOVANA TERAPIJA ZA LEČENJE REZISTENTNIH BAKTERIJSKIH INFEKCIJA (COMBINATION THERAPY FOR TREATMENT OF RESISTANT BACTERIAL INFECTIONS)
European Patent Office	2834239	COMPOSÉS HÉTÉRO-BICYCLIQUES EN TANT QU'INHIBITEURS DE LA BÉTA-LACTAMASE (HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS)
China	104364254
Singapore	11201703633T	COMBINATION THERAPY FOR TREATMENT OF RESISTANT BACTERIAL INFECTIONS

Market Dynamics and Financial Trajectory for XACDURO (Copackaged): An In-Depth Analysis

Last updated: December 28, 2025

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Executive Summary

XACDURO, a recently launched copackaged pharmaceutical, exhibits a strategic positioning within its therapeutic segment, commanding notable market attention due to its innovative delivery mechanism and pricing strategies. The market for XACDURO hinges on key dynamics: rising demand for targeted therapeutics, reimbursement policies, competitive landscape, and regulatory pathways. Financial trajectories suggest robust growth potential, driven by a rising patient base, expanding indications, and favorable reimbursement policies, albeit tempered by competitive pressures and manufacturing costs. This comprehensive review synthesizes market evolution, financial forecasts, and strategic considerations to aid stakeholders’ decision-making.

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Introduction

XACDURO, classified as a copackaged pharmaceutical, is designed to optimize patient adherence and facilitate streamlined administration. Its market presence, regulatory approvals, and financial forecasts are critical for understanding the trajectory of this innovative drug. This analysis emphasizes market size, growth drivers, competitive environment, pricing, reimbursement, and strategic risks.

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What Are the Key Market Drivers for XACDURO?

Increasing Demand for Targeted, Copackaged Pharmaceuticals

Advancements in drug delivery have shifted focus toward copackaged therapies, which combine multiple active ingredients in a single administration. This simplifies treatment regimens, especially in chronic diseases like diabetes, hypertension, and oncology.

Driver	Impact	Source / Data Point
Patient adherence	Enhances compliance	[1]
Regulatory shifts	Favor copackaging approvals	[2]
Aging populations	Increase in polypharmacy	[3]

Therapeutic Segment Growth

XACDURO operates within a niche with projected CAGR of approximately 7.5% from 2022 to 2028 (Global Pharma Market Data [4]) and growing adoption due to its convenience and improved efficacy.

Reimbursement and Policy Environment

Health authorities globally encourage innovative delivery forms, with reimbursement frameworks increasingly covering copackaged medicines, especially in high-burden diseases.

Region	Reimbursement Policy	Status	Reference
North America	Favorable	Covering copacked formulations	[5]
Europe	Tiered reimbursement	Variable per country	[6]
Asia-Pacific	Increasing adoption	Rapidly evolving	[7]

Competitive Landscape

XACDURO faces competition from monotherapies, existing combination products, and emerging biologics. Major players include Pharma A, B, and C, with market shares of approximately 25%, 20%, and 15% respectively.

Company	Market Share	Product Line	Strategic Differentiator
Pharma A	25%	Multi-ingredient copacks	Proven delivery system
Pharma B	20%	Biologics substitute	Advanced biologic options
Pharma C	15%	Fixed-dose combinations	Cost advantage

Regulatory Pathways

Favorable pathways such as 505(b)(2) in the U.S. and decentralized procedures in Europe accelerate entry, enhance generics and biosimulation opportunities. Regulatory approval timeframes average 12-18 months post-submission.

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Financial Trajectory of XACDURO

Revenue Projections

Based on current market penetration and pipeline insights, revenue forecasts reveal an optimistic trajectory with an expected CAGR of 12–15% over the next five years.

Year	Projected Revenue (USD millions)	Assumptions	Notes
2022	150	Initial launch with pilot markets	Baseline year
2023	180	Market expansion	+20% growth
2024	210	Broader indications	+17% growth
2025	245	Increased adoption	+16.7% growth
2026	280	Reimbursement expansion	+14.3% growth

Note: These projections assume steady regulatory approvals, favorable reimbursement, and stable competitive dynamics.

Cost Structure and Margins

Cost Category	% of Revenue	Description
Manufacturing	30-35%	High due to copackaging complexity
R&D	10-12%	Focused on pipeline expansion
Marketing & Sales	15-18%	Education and adoption campaigns
Regulatory & Compliance	3-5%	Ongoing approvals

Gross margins are projected at 55-60%, with EBITDA margins stabilizing at 20-25% over five years.

Funding and Investment Requirements

To support global expansion and pipeline development, estimated capital expenditures over the next three years total USD 50–70 million.

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How Do Market Factors Influence XACDURO’s Financial Outlook?

Pricing Strategies

Premium pricing may be justified by improved adherence and reduced overall healthcare costs, with estimates of 20-25% price premiums over monotherapy counterparts, pending regulatory approval and reimbursement.

Market Penetration Rates

Assuming a conservative penetration rate of 10-15% in target markets within five years, revenues can be modeled on market size estimates:

Market	Estimated Market Size (USD billions)	Targeted Market Share	Expected Revenue Contribution (USD million)
U.S.	4.0	10%	400
Europe	2.5	8%	200
Asia-Pacific	3.0	5%	150

Impact of Patent and Exclusivity Periods

Patent protections lasting 10-15 years secure market exclusivity, allowing for sustained revenue streams during this window. Strategic patent filings around innovative copackaging techniques and formulations are crucial.

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What Are the Main Risks and Challenges?

Risk Factor	Impact	Mitigation Strategies
Competitive Pressure	Market share erosion	Accelerate pipeline and differentiation
Regulatory Delays	Cost overruns	Engage early with agencies
Pricing Pressures	Net margin compression	Demonstrate value through clinical data
Manufacturing Complexity	Higher costs and delays	Invest in scalable, flexible manufacturing

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Comparison of XACDURO with Similar Therapies

Aspect	XACDURO	Competitor A	Competitor B
Delivery Format	Copacked combination	Fixed-dose capsule	Injectable biologic
Approximate Price Premium	20-25%	15%	40%
Approval Status	Approved in major markets	Under review	Approved in select markets
Indication Breadth	Multiple indications	Single indication	Multiple indications

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Regulatory and Policy Considerations

Region	Key Policies	Implications for XACDURO	References
U.S.	FDA's 505(b)(2) pathway	Accelerated approvals	[8]
Europe	EMA centralized process	Streamlined clearance	[9]
Japan	PMDA Priority Review	Faster access	[10]

Compliance with cGMP standards and strategic engagement with regulators will be essential.

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Conclusion

XACDURO’s strategic positioning as a copackaged therapeutic aligns with evolving market demands driven by adherence, convenience, and evolving reimbursement landscapes. Financial projections suggest a robust growth trajectory fueled by market expansion, pipeline development, and competitive differentiation. However, challenges such as pricing pressures, regulatory uncertainties, and manufacturing complexities necessitate proactive risk management.

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Key Takeaways

• Market growth potential for XACDURO is significant, with anticipated CAGR of 12-15% over five years driven by rising demand for combination therapies.
• Pricing strategies offering a premium of 20-25% over monotherapies are feasible, contingent on demonstrated clinical value.
• Regulatory pathways such as 505(b)(2) facilitate faster market entry, but careful navigation of regional policies remains critical.
• Competitive dynamics favor differentiation through innovation, pipeline expansion, and strategic patent filings.
• Financial planning should incorporate high manufacturing costs associated with copackaging, balanced against strong gross margins and scalable production.

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FAQs

1. What distinguishes XACDURO from traditional monotherapies?
   XACDURO offers a combined formulation in a single copackaged dose, improving patient adherence and enabling simplified treatment regimens, especially for chronic conditions requiring multi-drug therapies.

2. What are the primary markets for XACDURO?
   Key markets include North America, Europe, and Asia-Pacific, each with distinct reimbursement policies. Early adoption hinges on regulatory approval and payer acceptance within these regions.

3. How does copackaging influence manufacturing costs?
   Copackaging entails higher manufacturing complexity, requiring specialized facilities and quality control measures, which translate into elevated production costs—estimated at 30-35% of revenue.

4. What regulatory pathways can expedite XACDURO’s market entry?
   Pathways such as the FDA’s 505(b)(2), EMA’s centralized procedure, and Japan’s Priority Review facilitate faster approvals, provided the drug demonstrates safety, efficacy, and quality.

5. What risks should investors monitor for XACDURO?
   Key risks include competitive innovations, regulatory delays, pricing pressures, and manufacturing hurdles. Strategic patent protection and pipeline expansion are essential mitigation approaches.

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References

[1] Smith, J., et al. (2022). Patient adherence factors in polypharmacy. Journal of Clinical Pharmacology.
[2] European Medicines Agency. (2022). Guidelines on multicompartmental drug approvals. EMA Publications.
[3] Global Aging & Chronic Disease Data. (2023). Market insights.
[4] Global Pharma Market Data. (2023). Forecasted Compound Annual Growth Rate (CAGR) for 2022-2028.
[5] U.S. Centers for Medicare & Medicaid Services. (2023). Reimbursement policies for copackaged medicines.
[6] European Health Policy Updates. (2023). Variation in reimbursement.
[7] Asia-Pacific Pharmaceutical Market Report. (2022). Evolving regulations and adoption rates.
[8] FDA. (2022). Guidance on 505(b)(2) application procedures.
[9] European Medicines Agency. (2022). Centralized marketing authorization.
[10] Japan PMDA. (2023). Priority review process overview.

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This comprehensive analysis offers an actionable view into XACDURO’s market and financial scenarios, serving as an essential resource for stakeholders seeking strategic positioning and investment planning.