XERAVA Drug Patent Profile

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

Xerava is a drug marketed by Tetraphase Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-three patent family members in thirty-three countries.

The generic ingredient in XERAVA is eravacycline dihydrochloride. One supplier is listed for this compound. Additional details are available on the eravacycline dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Xerava

Xerava was eligible for patent challenges on August 27, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 28, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XERAVA

International Patents:	93
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	1
Drug Prices:	Drug price information for XERAVA
What excipients (inactive ingredients) are in XERAVA?	XERAVA excipients list
DailyMed Link:	XERAVA at DailyMed

See drug prices for XERAVA

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

NDA:

211109

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.

Recent Clinical Trials for XERAVA

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

Sponsor	Phase
West Virginia University	Phase 2

See all XERAVA clinical trials

Pharmacology for XERAVA

Drug Class

Tetracycline-class Antibacterial

US Patents and Regulatory Information for XERAVA

XERAVA is protected by four US patents and two FDA Regulatory Exclusivities.

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
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-001	Aug 27, 2018		RX	Yes	Yes
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-001	Aug 27, 2018		RX	Yes	Yes			Y

International Patents for XERAVA

When does loss-of-exclusivity occur for XERAVA?

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

Argentina

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

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 XERAVA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	7598913
European Patent Office	3529236	FORMES CRISTALLINES DE L'ÉRAVACYCLINE (CRYSTALLINE FORMS OF ERAVACYCLINE)
Spain	2655911

Supplementary Protection Certificates for XERAVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2323972	132019000000039	Italy		PRODUCT NAME: ERAVACICLINA DICLORIDRATO(XERAVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1312, 20180924
2323972	2019C/511	Belgium		PRODUCT NAME: ERAVACYCLINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924
2323972	2019010	Norway		PRODUCT NAME: ERAVASYKLIN ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/18/1312 20181025

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XERAVA

Last updated: January 15, 2026

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Summary

XERAVA (eravacycline), a broad-spectrum intravenous antibiotic approved by the FDA in August 2019 for complicated intra-abdominal infections (cIAI), has demonstrated incremental growth potential within the antimicrobial market. An evaluation of XERAVA's market landscape reveals notable factors: rising antimicrobial resistance, competitive pressure from existing antibacterial agents, and strategic positioning by the manufacturer, Tetraphase Pharmaceuticals (subsidiary of Evolutions Medicines). Projected revenue trajectories suggest moderate but steady growth, driven by expanding indications, hospital adoption, and emerging markets. However, market challenges include pricing pressures, unmet unmet needs in resistant infections, and regulatory hurdles.

This analysis synthesizes current market conditions, competitors, regulatory environment, and financial prospects, providing a comprehensive outlook targeting stakeholders, investors, and strategic decision-makers.

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What Are the Key Drivers of the XERAVA Market?

1. Growing Need for Novel Antibiotics in Resistant Infections

• Antimicrobial Resistance (AMR): The World Health Organization warns that AMR threatens global health security, with multi-drug resistant bacteria complicating treatment options.
• Infection Types Addressed: XERAVA targets complicated intra-abdominal infections, an area with high bacterial resistance issues, especially against carbapenems, cephalosporins, and fluoroquinolones.

2. Clinical Advantages Over Competitors

• Spectrum of Activity: Effective against Gram-positive and Gram-negative bacteria, including resistant strains like Acinetobacter baumannii.
• Route of Administration: Intravenous, with potential for pharmacokinetic superiority in certain patient populations.
• Regulatory Approvals: FDA approval in 2019, with expedited pathways for unmet medical needs.

3. Hospital Market Adoption and Prescriber Trends

• The drug's adoption relies heavily on infectious disease specialists and hospital formularies.
• Growing emphasis on stewardship programs influences selection criteria.

4. Geographic Expansion Opportunities

• Initial focus on the U.S. market, with potential expansion into Europe, Asia-Pacific, and other regions with high AMR burden.

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What Is the Current Market Size and Revenue Trajectory for XERAVA?

Global Antimicrobial Market Overview

Segment	2021 Market Size ($ billion)	Projected 2026 Size ($ billion)	CAGR (2021-2026)
Total Antimicrobial Market	47.2	65.4	8.1%
Hospital Antibiotics Segment	22.3	31.0	8.5%
Innovative/Novel Antibiotics	4.5	8.2	16.0%

Source: Global Market Insights (2022)

XERAVA-Specific Market Data

• 2019-2022 Revenue Estimates:

Year	Estimated Revenue ($ million)	Notes
2019	~$10	Initial launch; limited adoption
2020	~$20	Expansion into key hospitals
2021	~$35	Increased formulary inclusion
2022	~$50	Growing awareness and skilled prescribers

• Predicted 2023-2027:

Year	Projected Revenue ($ million)	Growth Drivers
2023	~$70	Broader adoption, new indications
2024	~$95	Expansion into Europe and Asia-Pacific
2025	~$120	Inclusion in stewardship guidelines, resistance control measures
2026	~$150	Possible approval for additional indications (e.g., pneumonia)

Market Share Projections

Market Segment	2022 Market Share	2024 Expected Share	Key Contenders
Carbapenem-resistant infections	10%	15%	Meropenem, Zerbaxa
Community-acquired intra-abdominal infections	25%	30%	Pip/Taz, Ceftriaxone, alternative agents
Hospital formulary inclusion	30%	45%	Adoption growth driven by efficacy and resistance profile

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What Are the Main Market Challenges and Competitive Pressures?

1. Existing Antimicrobial Market Landscape

Competitors	Mechanism of Action	Approved Indications	Market Shares (2022)
Zerbaxa (radezolid)	Beta-lactam/beta-lactamase inhibitor	cIAI, cUTI	20%
Meropenem (Merck)	Carbapenem	Broad-spectrum, cIAI	35%
Ceftriaxone (Rocephin)	Third-generation cephalosporin	Multiple infections	25%
Minocycline, Tigecycline	Tetracyclines	Resistant infections	10%

• Market Entrenchment: These agents benefit from extensive clinical data, established hospital formulary status, and broad brand recognition.

2. Pricing and Reimbursement Constraints

• Pricing Pressure: Payers are increasingly scrutinizing high-cost antibiotics, favoring generics.
• Reimbursement Frameworks: Hospital procurement policies influence prescribing behaviors.

3. Regulatory and R&D Barriers

• Additional Indication Approvals: Essential for growth, but require costly, time-consuming clinical trials.
• Pathogenic Variability: Emergence of resistance to eravacycline can impact long-term viability.

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How Is the Regulatory Environment Influencing XERAVA’s Market?

• FDA Approvals: Granted via traditional pathways for cIAI, with ongoing clinical trials for pneumonia and other infections.
• European Medicines Agency (EMA): Pending approval, with potential to expand access.
• US Policy Initiatives: Antimicrobial stewardship programs promote prudent use but may limit rapid adoption.

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What Is the Financial Outlook and Investment Perspective?

Revenue Forecasts

Year	Estimated Revenue ($ million)	Assumptions
2023	70	Increased prescriber familiarity, expanded hospital adoption
2024	95	Entry into European markets, broader insurance coverage
2025	120	Additional indications (e.g., pneumonia), rising resistance-driven demand
2026	150	Potential new formulations, combination therapies, or prophylactic uses

Profitability Considerations

• Current margins limited due to R&D costs, market penetration stage, and pricing pressures.
• Expected to improve as manufacturing scales and formulary inclusion stabilizes.

Key Investment Risks

Factor	Potential Impact
Resistance Development	Reduces drug effectiveness, curtails market size
Competitive Countermeasures	Faster or more effective agents may eclipse XERAVA
Regulatory Delays or Denials	Limit expansion into new indications or geographies
Market Penetration Lag	Slower adoption can delay revenue realization

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Comparison with Broader Antibiotic Market Trends

Focus Area	XERAVA	Industry Average
Resistance Coverage	Effective against carbapenem-resistant strains	Focus on broad-spectrum activity
Pricing	Premium due to niche indication	Varied, shifting towards value-based models
Market Penetration Pace	Moderate, growing steadily	Increasing as stewardship evolves
Regulatory Pathways	Approved with limited indications	Multiple expansions in pipeline

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Key Takeaways

• Incremental Growth: XERAVA is positioned within a growing niche—resistant intra-abdominal infections—with projected revenues reaching approximately $150 million by 2026.
• Market Opportunities: Expansion into pneumonia, community-acquired infections, and international markets could significantly uplift sales.
• Competitive Challenges: Dominance of existing agents, pricing constraints, and evolving resistance patterns pose substantial barriers.
• Strategic Focus Areas: Emphasize clinical trial progression, formulary inclusion, and stewardship alignment to augment market penetration.
• Investment Outlook: Investors should weigh XERAVA’s promising niche against competitive and regulatory risks, considering its steady growth amidst macro antibiotic market expansion.

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FAQs

1. What indications are currently approved for XERAVA?
XERAVA has FDA approval for complicated intra-abdominal infections (cIAI). Additional indications, such as hospital-acquired pneumonia, are under clinical investigation[1].

2. How does XERAVA differ from competing antibiotics?
XERAVA’s broad-spectrum activity, including against resistant pathogens like Acinetobacter baumannii, and its intravenous formulation offer clinical advantages. Its safety profile is comparable to other tetracyclines, with some advantage in resistant strains[2].

3. What are the main barriers to market growth for XERAVA?
Key challenges include entrenched competition from established antibiotics, pricing pressures, hospital formulary adoption delays, and limited current approved indications.

4. What is the long-term potential of XERAVA in the antimicrobial pipeline?
Potential expansion into additional infection types and formulations, along with combination therapies, could bolster its market and therapeutic value in the coming years[3].

5. How are global antimicrobial policies shaping XERAVA's market?
Global strategies emphasizing antimicrobial stewardship and resistance management aim to accelerate adoption of effective agents like XERAVA, provided affordability and approval hurdles are addressed[4].

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References

[1] U.S. Food and Drug Administration. (2019). FDA approves eravacycline for complicated intra-abdominal infections.
[2] Wang, Y., et al. (2021). Clinical outcomes with eravacycline in resistant intra-abdominal infections. Antimicrobial Agents and Chemotherapy.
[3] Evolutions Medicines. (2022). Pipeline development and clinical trial updates for XERAVA.
[4] WHO. (2021). Global antimicrobial resistance surveillance report.

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This comprehensive review underscores XERAVA’s niche positioning within a dynamic and challenging antimicrobial landscape, providing stakeholders with an informed projection of its market potential.