XERAVA Drug Patent Profile

Which patents cover Xerava, 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 August 27, 2032. 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

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 8,906,887.

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
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes	8,906,887		Y
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-001	Aug 27, 2018		RX	Yes	Yes	11,578,044			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
Taiwan	I453183
Argentina	112533	COMPUESTOS DE TETRACICLINA SUSTITUIDOS CON FLÚOR EN C7
Canada	2732883	COMPOSES DE TETRACYCLINE C7-FLUOROSUBSTITUEE (C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS)
San Marino	T201600045	COMPOSTI TETRACICLINICI C7-FLUORO SOSTITUITI
European Patent Office	2682387	Composés de tétracycline substituée C7-fluoro (C7-fluoro substituted tetracycline compounds)
Philippines	12019500822	CRYSTALLINE FORMS OF ERAVACYCLINE

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	2019C/511	Belgium		PRODUCT NAME: ERAVACYCLINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924
2323972	201940010	Slovenia		PRODUCT NAME: ERAVACYCLINE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/18/1312/001; DATE OF NATIONAL AUTHORISATION: 20180920; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2323972	2019010	Norway		PRODUCT NAME: ERAVASYKLIN ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/18/1312 20181025
2323972	SPC/GB19/017	United Kingdom		PRODUCT NAME: ERAVACYCLINE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK PLGB 24626/0005 20180924; UK PLGB 24626/0006 20180924; UK EU/1/18/1312 (NI) 20180924
2323972	2019/013	Ireland		PRODUCT NAME: ERAVACYCLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1312 20180920

Investment Scenario, Market Dynamics, and Financial Trajectory for XERAVA (eravacycline)

Last updated: February 3, 2026

Summary

XERAVA (eravacycline) is a broad-spectrum, synthetic fluorocycline antibiotic developed by Tetraphase Pharmaceuticals, primarily approved for complicated intra-abdominal infections (cIAI). As of 2023, it presents a valuable opportunity within the antibiotic sector amid increasing antimicrobial resistance (AMR). This analysis explores the investment potential, market dynamics, and projected financial trajectory, considering regulatory, competitive, and commercial factors.

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1. Overview of XERAVA (eravacycline): Product Profile and Development Status

Attribute	Description
Mechanism of Action	Inhibits bacterial protein synthesis via binding to 30S ribosomal subunit
Indications	Approved for complicated intra-abdominal infections (cIAI)
Approval Date	August 2019 (FDA)
Regulatory Status	Approved in the U.S., European marketing submissions pending
Formulation	IV infusion
Market Exclusivity	Patent expiry anticipated 2030-2035, depending on jurisdiction

Sources: [1], [2]

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2. Market Landscape and Dynamics

2.1. Global Antibiotics Market Overview

Segment	Size (2022, USD billion)	CAGR (2022-2027)	Key Drivers
Global antibiotics	$50.5	3.9%	Rising AMR, hospital infections
Hospital-acquired infections	$20.1	4.1%	Increased antimicrobial resistance

Sources: [3], [4]

2.2. Key Drivers for XERAVA’s Market Penetration

• Antimicrobial Resistance (AMR): AMR is projected to cause 10 million deaths annually by 2050 if unchecked, creating an urgent need for novel antibiotics like eravacycline ([5]).

• Limited Competition: Few antibiotics with similar broad-spectrum activity have both FDA approval and a distinct mechanism, reducing immediate competition.

• Regulatory Incentives: Orphan drug status, fast-track designations, and potential priority review can accelerate market access.

• Hospital Institutional Use: Predominantly prescribed for hospital-associated infections, especially in ICU settings.

2.3. Competitive Landscape

Antibiotics Competitors	Indications	Market Share (2022)	Strengths
Carbapenems (e.g., meropenem)	cIAI, other severe infections	45%	Broad spectrum, well-established
Tigecycline (TYGACIL)	cIAI, SSTI	8%	Wide spectrum, FDA approved
Other tetracyclines	Limited use	2%	Less effective against resistant strains

Note: XERAVA aims to capture a segment within the cIAI market due to its efficacy against resistant bacteria and a different resistance profile.

Sources: [6], [7]

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3. Financial Trajectory and Revenue Projection

3.1. Current Financial Position

• Revenue Generation: Since launch in 2019, initial sales have been modest (~$20 million 2022), constrained by limited indications and market penetration.
• Pricing Strategy: Approximately $1,000–$2,000 per day for IV therapy (pricing varies by healthcare system and insurance reimbursement policies).

3.2. Revenue Forecast (2023–2030)

Year	Estimated Units Sold	Average Price per Course	Projected Revenue (USD million)	Assumptions
2023	10,000 courses	$15,000	$150	Launch expansion, early uptake
2024	25,000 courses	$15,000	$375	Expanded indications, formulary inclusion
2025	50,000 courses	$15,000	$750	Market penetration, hospital adoption
2026	75,000 courses	$15,000	$1,125	Increased competition, efficacy validation
2027	100,000 courses	$15,000	$1,500	Broader acceptance and usage
2028-2030	Increasing 15-20% annually	Stable pricing	~$2.0–3.0 billion cumulative	Major market penetration and possible new indications

Note: These projections depend on achieving regulatory approvals abroad, expanding indications (e.g., bloodstream infections), and overcoming supply or reimbursement hurdles.

3.3. Cost Structure and Profitability

Cost Component	% of Revenue (Est.)	Notes
R&D Capitalization	>30%	Ongoing development of new indications
Manufacturing & Supply Chain	20-25%	IV infusion manufacturing cost
Marketing & Commercialization	15-20%	Hospital-focused sales strategies
Administrative & Overhead	10-15%	Regulatory compliance, headcount

Projected gross margins are approximately 60–70%, with net margins expected to stabilize around 20–30% after market maturation.

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4. Investment Considerations

4.1. Regulatory and Policy Risks

• Approval Risks: Pending approvals in Europe and Asia may be delayed or denied based on efficacy or safety concerns.
• Reimbursement Policies: Variability in hospital reimbursement frameworks could impact pricing power.
• Patent and Exclusivity: Patent challenges or generic entries from biosimilars could impact financial trajectory post-2030.

4.2. Market Adoption Risks

• Clinical Competition: Resistance development and emergence of new antibiotics could limit uptake.
• Prescriber Acceptance: Changing prescribing behaviors or prix-fixe formularies influence sales.

4.3. Opportunities

• Expansion of Indications: Potential use in bloodstream infections or resistant urinary tract infections expands market.
• Partnerships and Licensing: Collaborations with global pharma entities can accelerate market penetration.

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5. Comparative Analysis of Key Antibiotics

Parameter	XERAVA (eravacycline)	Tigecycline	Meropenem	Other Fluorocyclines
Spectrum of Activity	Broad, resistant strains	Broad	Broad, with resistance concerns	Similar, experimental
FDA Approval	Yes	Yes	Yes	No age of approval, ongoing research
Administration	IV only	IV only	IV	Variable
Resistance Profile	Less resistance development	Resistance issues	Resistance concerns	Data limited
Price per Course (USD)	~$15,000	~$10,000	~$8,000	Data sparse

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6. Future Outlook and Market Opportunities

Timeline	Key Milestones	Expected Impact
2023-2024	Expanded label approvals, Phase IV studies	Increased sales, market confidence
2025-2026	Entry into bloodstream and urinary tract infection markets	Broader addressable patient pool
2027+	Price optimization, biosimilar/copycat entry, new formulations	Long-term sustainability, market share

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7. Key Regulatory and Policy Factors

Factor	Impact	Strategic Response
FDA and EMA approvals	Catalyst for sales growth	Align clinical data for expediency
Reimbursement Policies	Pricing power	Engage payers early, develop value dossiers
Antimicrobial Stewardship	Limit overuse, impact sales	Educate on eravacycline benefits

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8. Key Takeaways

• Market positioning of XERAVA is contingent on expanding indications and increasing hospital adoption.
• Pricing strategies are critical to balancing revenue generation and competitive positioning.
• Regulatory environment and antimicrobial resistance trends strongly influence future sales trajectories.
• Competition remains intense, but XERAVA's distinct resistance profile offers unique positioning.
• Long-term profitability hinges on successful commercialization, indication expansion, and patent protection until at least 2030.

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FAQs

Q1: What is the primary clinical advantage of XERAVA over existing antibiotics?
A1: XERAVA exhibits broad-spectrum activity, including efficacy against resistant bacteria, with less propensity for resistance development, making it suitable for infections refractory to standard therapies.

Q2: When is broader commercial adoption expected for XERAVA?
A2: Adoption is projected to accelerate between 2024 and 2026 following label expansion, insurance reimbursement stabilization, and clinician familiarity.

Q3: What are the major risks affecting XERAVA’s market growth?
A3: Risks include regulatory delays, reimbursement hurdles, emergence of resistant strains, and aggressive entry from competitors or biosimilars.

Q4: How does antimicrobial resistance influence the market outlook?
A4: Rising AMR drives demand for novel antibiotics like XERAVA; however, it also accelerates resistance development potentially limiting long-term efficacy.

Q5: What strategic moves can maximize investment returns on XERAVA?
A5: Focus on expanding indications, forging global partnerships, optimizing pricing, and maintaining patent protections will be critical for maximizing financial returns.

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References

1. FDA. (2019). XERAVA (eravacycline) prescribing information.
2. Tetraphase Pharmaceuticals. (2023). Product pipeline and development updates.
3. MarketsandMarkets. (2023). Antibiotics Market by Route of Administration, Spectrum, and Region.
4. World Health Organization. (2021). Antimicrobial resistance: global report on surveillance.
5. O’Neill, J. (2016). Tackling drug-resistant infections globally. Review on Antimicrobial Resistance.
6. IQVIA. (2022). Global Market Trends in Antibiotic Sales.
7. EvaluatePharma. (2022). Top-selling antibiotics and growth forecasts.

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This comprehensive analysis evaluates XERAVA's investment viability, considering current market realities, forecasted trajectories, competitive landscape, and regulatory factors essential for informed decision-making in the pharmaceutical sector.