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 October 19, 2037. 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

Constraining patent/regulatory exclusivity:

10,961,190

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.

This potential generic entry date is based on patent 10,961,190.

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	8,796,245
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes	8,796,245
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-001	Aug 27, 2018		RX	Yes	Yes	8,906,887		Y
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes

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:

China

Croatia

Denmark

European Patent Office

Hungary

Japan

Morocco

Philippines

Poland

Singapore

Slovenia

South Korea

Spain

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	2014148509
Brazil	PI0916985
Japan	5690957
San Marino	T201600045	COMPOSTI TETRACICLINICI C7-FLUORO SOSTITUITI

Supplementary Protection Certificates for XERAVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2323972	CA 2019 00009	Denmark		PRODUCT NAME: ERAVACYCLIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1312 20180209
2323972	2019010	Norway		PRODUCT NAME: ERAVASYKLIN ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/18/1312 20181025
2323972	122019000024	Germany		PRODUCT NAME: ERAVACYCLIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1312 20180920
2323972	2019/013	Ireland		PRODUCT NAME: ERAVACYCLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1312 20180920

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug XERAVA

Last updated: July 27, 2025

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Introduction

XERAVA (eravacycline) is a novel intravenous antibiotic developed by Tetraphase Pharmaceuticals, approved by the FDA in August 2018 for complicated intra-abdominal infections (cIAIs) in adults. As bacterial resistance trends escalate globally, the demand for innovative antimicrobial agents like XERAVA intensifies. This analysis evaluates the current market dynamics and potential financial trajectory of XERAVA, considering factors influencing its adoption, competitive landscape, regulatory environment, and revenue projections.

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Market Overview and Therapeutic Landscape

Global Intra-Abdominal Infection (IAI) Market

The global intra-abdominal infection market remains sizable, driven by increasing surgical procedures, rising antimicrobial resistance, and the need for effective therapies. The market size was valued at approximately USD 2.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2030, partly fueled by expanding indications for injectable antibiotics [1].

Antimicrobial Resistance (AMR) and Unmet Need

A significant driver for XERAVA’s market potential is the expanding AMR crisis. Traditional antibiotics, notably carbapenems and cephalosporins, face diminishing efficacy due to resistant pathogens such as carbapenem-resistant Enterobacteriaceae (CRE) and extended-spectrum beta-lactamase (ESBL) producers. As a novel tetracycline derivative active against resistant strains—including multi-drug resistant Acinetobacter baumannii and resistant Enterobacteriaceae—XERAVA addresses a critical therapeutic gap.

Positioning and Differentiation

XERAVA's broad-spectrum activity, including efficacy against multidrug-resistant organisms, positions it as an alternative in settings where resistance compromises conventional agents. Its intravenous formulation aligns with hospital-based administration, making it particularly suitable for severe intra-abdominal infections where oral options are insufficient.

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Market Dynamics Influencing XERAVA

Regulatory Factors and Approvals

Post-approval, XERAVA's utilization hinges on institutional protocol updates and guideline endorsements. The lack of extensive head-to-head clinical trials against standard-of-care antibiotics initially limited its adoption. However, accumulating real-world evidence and inclusion in clinical guidelines could propel its uptake.

Competitive Landscape

XERAVA faces competition from established antibiotics such as ertapenem, meropenem, and piperacillin-tazobactam, all widely used for IAI. Its niche is further defined by its activity against resistant organisms where traditional agents are less effective.

Other newer agents like plazomicin and spectinomycin-based combinations also target resistant pathogens but differ in administration routes and spectrum. Moreover, the rising adoption of combination therapies can influence XERAVA’s market share.

Pricing and Reimbursement

Pricing strategies impact XERAVA’s market penetration. As a newly approved, specialized antibiotic, it commands premium pricing (> USD 3000 per vial). Reimbursement policies and antimicrobial stewardship programs exert pressure on utilization, favoring cautious, evidence-based use to prevent resistance.

Hospital Adoption and Prescriber Acceptance

Hospital formularies largely dictate initial access. As of 2022, XERAVA’s inclusion in major hospital protocols remains limited but growing. Prescriber familiarity and clinical data influence adoption rates. Furthermore, stewardship initiatives aim to reserve broad-spectrum antibiotics for resistant cases, affecting volume growth.

Supply Chain and Manufacturing

Manufacturing capacity for XERAVA must meet demand amid global supply chain disruptions. Reliable supply chains are crucial for maintaining market confidence, especially in acute care settings.

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Financial Trajectory and Revenue Projections

Market Penetration Estimates

Forecasting XERAVA’s revenue involves evaluating its addressable market, competitive positioning, and acceptance rate. Given the global IAI market and resistance challenges, conservative estimates project:

• Year 1–2 (2023–2024): Market entry stage with limited adoption. Revenue estimated at USD 20–40 million, primarily from North American hospitals.
• Year 3–4 (2025–2026): Growing acceptance with expanded formulary inclusion, clinical guideline endorsements, and increased prescriber familiarity. Revenue potential rises to USD 80–150 million.
• Year 5+ (2027+): Potential plateau as market penetration stabilizes or expands into outpatient settings through intravenous-to-oral switch strategies, possibly reaching USD 200+ million globally. Key growth drivers include expanding indications, broader geographic access, and real-world efficacy data.

Geographic Expansion

While initial focus remains North America, Europe and Asia-Pacific represent significant growth opportunities due to rising bacterial resistance and unmet needs for novel therapies. Regulatory approvals in these regions could amplify revenue streams.

Pricing and Volume Dynamics

XERAVA’s premium price points constrain volume growth but may sustain revenues if utilization remains restricted to resistant cases. Conversely, increased advocacy, stewardship, and evidence of superior efficacy could justify broader use and higher volumes.

Impact of Patent Exclusivity and Competition

Patent protection—originally granted until 2030—provides revenue certainty. However, generic versions or biosimilar competition could emerge post-expiry, impacting profitability.

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Challenges and Opportunities

Challenges

• Limited clinical data initially impeded widespread adoption.
• Stewardship programs limit broad usage due to concerns over resistance development.
• Pricing pressures may challenge margins, especially in cost-sensitive markets.
• Resistance evolution could diminish efficacy over time, necessitating continual surveillance and development.

Opportunities

• Expansion into other indications such as complicated urinary tract infections.
• Inclusion in clinical guidelines could accelerate in-hospital use.
• Combination therapies targeting resistant pathogens could open new markets.
• Partnerships with healthcare providers to integrate XERAVA into antimicrobial stewardship protocols.

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Strategic Outlook

XERAVA’s market trajectory hinges on demonstrating superior clinical efficacy, establishing stewardship policies, and expanding global access. Active engagement with health authorities, continuous data generation, and strategic pricing will shape its financial success.

Long-term earnings depend on how effectively Tetraphase and potential licensees navigate resistance challenges, broaden indications, and integrate XERAVA into hospital formularies.

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Key Takeaways

• The global intra-abdominal infection market offers a substantial and growing opportunity for XERAVA, especially amid rising antimicrobial resistance.
• XERAVA’s unique activity profile against resistant pathogens positions it as a specialized therapy, but market penetration remains constrained by competition, pricing, and stewardship protocols.
• Realistic revenue projections suggest initial revenues of USD 20–40 million, with growth potential reaching USD 200 million+ within five years, contingent on adoption, guideline inclusion, and geographic expansion.
• Challenges such as access, resistance, and competition must be strategically managed through clinical data, partnerships, and stewardship integration.
• Proactive positioning and continuous evidence development are vital for maximizing XERAVA’s financial trajectory within the evolving antimicrobial landscape.

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FAQs

1. What are the primary therapeutic advantages of XERAVA over existing antibiotics?
XERAVA exhibits potent activity against multidrug-resistant organisms, including certain carbapenem-resistant strains, offering an alternative where traditional antibiotics fail.

2. How does antimicrobial stewardship influence XERAVA’s market potential?
Stewardship programs restrict broad-spectrum antibiotic use to preserve efficacy, which can limit initial utilization but also enhance its reputation as a targeted, reserved therapy against resistant infections.

3. What is the anticipated timeline for XERAVA’s revenue growth?
Initial revenues are expected in 2023–2024 with gradual growth. Significant expansion may occur over 3–5 years as clinical data, guidelines, and global access improve.

4. How does geographic expansion impact XERAVA’s financial outlook?
Entering European and Asia-Pacific markets can substantially increase sales, particularly as resistance patterns favor new agents, provided regulatory and reimbursement pathways are navigated efficiently.

5. What are key factors that could hinder XERAVA’s market penetration?
Competitive efficacy, pricing constraints, restrictive stewardship policies, and emerging resistance could slow uptake; conversely, supportive clinical data and guideline endorsement can accelerate growth.

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References

[1] MarketsandMarkets. Antimicrobial Market. 2022.
[2] FDA. XERAVA (eravacycline) prescribing information. 2018.
[3] Global Data. Intra-abdominal infections market analysis. 2022.