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 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
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:

8,906,887

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 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
China	110582486
China	117903083
Denmark	3529236
European Patent Office	3529236	FORMES CRISTALLINES DE L'ÉRAVACYCLINE (CRYSTALLINE FORMS OF ERAVACYCLINE)
Spain	2978198
Croatia	P20240605

Supplementary Protection Certificates for XERAVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2323972	300971	Netherlands		PRODUCT NAME: ERAVACYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/18/1312 20180924
2323972	122019000024	Germany		PRODUCT NAME: ERAVACYCLIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1312 20180920
2323972	PA2019009	Lithuania		PRODUCT NAME: ERAVACIKLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1312 C(2018)6231 20180920
2323972	LUC00107	Luxembourg		PRODUCT NAME: ERAVACYCLINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: 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	CA 2019 00009	Denmark		PRODUCT NAME: ERAVACYCLIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1312 20180209

XERAVA (Eravacycline) Market Dynamics and Financial Trajectory: Sales, Uptake, Pricing Pressure, and Competitive Patent/Generic Risks

Last updated: June 19, 2026

XERAVA (eravacycline) is a late-entry IV antibiotic in a high-resistance, stewardship-driven market where share gains depend on hospital formulary access and conversion from alternative agents. Commercial momentum has been constrained by concentrated use (serious infections requiring IV therapy), strong entrenched competitors (including carbapenems, tigecycline, and newer agents in specific settings), and the practical limits of new antibiotic adoption cycles. Financial trajectory has therefore tracked hospital adoption rather than broad outpatient expansion.

How is XERAVA (eravacycline) performing in the hospital antibiotic market?

XERAVA is marketed for complicated intra-abdominal infections (cIAI) and has been positioned around safety and efficacy relative to older tetracyclines, with emphasis on dosing convenience and a differentiated safety profile versus tigecycline in key analyses. In practice, uptake is driven by:

• ID/pharmacy committees at large hospital systems
• Restricted formularies tied to stewardship criteria
• Budget impact from 340B, MAC contract pricing, and system-level GPO rebates
• Clinician familiarity with standard of care (SoC) IV antibiotics

What is the commercial base for eravacycline (cIAI)

The cIAI market is typically served by:

• Carbapenems (eg, meropenem, imipenem-cilastatin, ertapenem in selected cases)
• Penicillin/beta-lactam combinations
• Fluoroquinolones plus metronidazole in lower-acuity settings
• Tigecycline in certain intra-abdominal patterns
• Newer agents depending on resistance epidemiology and local guidelines

XERAVA competes within this framework, where formulary inclusion is a prerequisite to consistent ordering.

Why adoption can be slower for hospital antibiotics

Hospital antibiotic adoption is a function of:

• Local antibiograms and resistance trends
• Clinical pathway alignment (order sets, approval rules)
• Stewardship scoring and “line of therapy” placement
• Switching friction from current preferred agents

A late entrant faces inertia and budget scrutiny, especially when competitors have established utilization norms.

What pricing and contracting dynamics affect XERAVA revenue?

Hospital antibiotics are exposed to net price compression through:

• Rebates and discounts under GPO and managed care contracting
• System formulary negotiations that push down ASP over time
• Stepped pricing based on volume tiers

XERAVA’s financial profile therefore depends on realized net price, not launch list pricing.

Does XERAVA face drug class or category pricing pressure?

Yes, via two overlapping mechanisms:

1. Competitor-driven benchmarks: carbapenems and established IV agents set a pricing baseline in many systems.
2. Stewardship-driven use: if XERAVA is placed in a narrower formulary bucket, volume stays modest and fixed costs weigh on profitability.

What drives net revenue volatility in this category

Revenue can swing with:

• Changes in hospital antibiotics utilization protocols
• Pharmacy director changes and committee re-tiering
• Contract renegotiations and tender outcomes
• Pediatric or resistance-driven pathway changes (where relevant)

How does XERAVA’s financial trajectory compare with other new IV antibiotics?

XERAVA has followed the typical trajectory of hospital-only antibiotics: modest uptake after launch, periodic gains from formulary expansions, and slower growth when broad replacement of entrenched SoC does not occur.

In contrast, antibiotics that scale quickly usually have at least one of the following:

• Broad, non-restricted indications that expand eligible patient populations
• A strong “substitution” effect where standard-of-care conversion is easy
• Clear stewardship advantage in key subpopulations that drives repeated ordering

XERAVA’s growth has largely depended on institution-by-institution conversion for serious intra-abdominal infections.

What are the key drivers of XERAVA market share gains or losses?

Market share outcomes are determined by three interacting levers.

Formulary placement and utilization controls

If XERAVA is:

• preferred for cIAI within an order set, it benefits from automatic consideration
• non-preferred, it requires prescriber justification and can lose orders even when clinicians perceive utility

Clinical guideline fit and real-world outcomes

Clinician confidence increases orders when real-world outcomes align with pivotal trial messaging, including:

• cure and failure rates
• safety signals relative to alternative regimens
• tolerability and dosing practicality

Competitive switching

Even with differentiated safety, clinicians may keep using:

• carbapenems for broad coverage
• tigecycline if already stocked and accepted
• combination regimens based on local resistance patterns

Conversion to XERAVA is a formulary and pathway decision as much as a clinical choice.

When does XERAVA lose exclusivity, and what does that imply for revenue risk?

Revenue risk for XERAVA hinges on:

• patent expiration timing
• strength and breadth of composition, formulation, and method-of-use claims
• whether FDA regulatory exclusivity or data exclusivity blocks generic approval

What generic entry risks exist for eravacycline?

Because XERAVA is an antibiotic with a constrained but critical inpatient use pattern, the economic impact of generic entry is usually meaningful even if total volumes remain stable. The core question for investors and licensors is not whether generic eravacycline will be used at all, but whether managed-care contracting and formularies will switch quickly after approval.

How biosimilar risk does not apply

XERAVA is a small-molecule drug. Biosimilar pathways do not apply. The competitive set is primarily generics and, in some cases, authorized generics depending on rights.

What patent estate protects XERAVA, and how strong is it against Paragraph IV filings?

A full patent-strength assessment requires the Orange Book listing and the active patent set tied to each dosage form and condition of use. For an antibiotic like eravacycline, the typical protection stack may include:

• composition of matter
• polymorph/crystal forms
• formulations and stability
• manufacturing process improvements
• method-of-use for cIAI

Which patents matter most for launch-blocking

For a generic filing, the highest-leverage claims are usually:

• composition-of-matter claims that cover eravacycline itself
• formulation claims tied to IV delivery stability
• manufacturing/process claims that are harder to “design around”

How settlement agreements can shape post-expiration revenue

If a Paragraph IV challenge results in a settlement, it can shift generic launch dates and preserve branded revenue. Settlement terms can include:

• delayed launch windows
• permitted product entry dates
• non-impairment provisions
• cross-licenses

What is the Orange Book status of XERAVA, and what does it signal for generic timelines?

Orange Book status determines:

• listed patents per NDA
• patent-specific expiration and potential triggering events for generic approval
• any periods of exclusivity beyond patent expiration

Why Orange Book granularity matters

Different patent types can expire at different times. A generic may be blocked by one strong composition claim even if another formulation claim expires earlier. The market impact depends on whether the earliest expiring listed patents are capable of being worked around.

What FDA regulatory pathway and exclusivity affects XERAVA’s commercial durability?

XERAVA’s FDA record shapes generic entry risk through:

• exclusivity type at launch (application and pediatric or other exclusivities, if any)
• data exclusivity barriers to generic approval
• any changes to labeling and conditions of use over time

How label restrictions affect eligible generic indications

If labels narrow to a specific infection type or severity threshold, generic substitution can be slower, because not every indication maps cleanly to prescribing practice.

Who are the main competitors versus XERAVA in complicated intra-abdominal infections?

In cIAI, competitive pressure usually comes from:

• carbapenems (broad coverage in serious intra-abdominal infections)
• tigecycline (historically used in intra-abdominal infections)
• beta-lactam/beta-lactamase inhibitor regimens (depending on local susceptibility patterns)
• newer agents in resistant subsets (depending on institutional antibiograms)

The key competitive metric is not just efficacy, it is:

• formulary preference
• ease of switching
• stewardship approval thresholds
• total length-of-therapy and IV-to-PO conversion pathways

How does XERAVA compare with tigecycline and carbapenems in clinical and economic terms?

Relative differentiation that impacts real-world use usually includes:

• safety and tolerability considerations that affect length of therapy and discontinuation
• dosing and administration that affect workflow
• perceived resistance coverage and empiric regimen fit

Economically, hospitals select the agent that best matches stewardship and budget rules, with efficacy serving as a prerequisite rather than sole determinant.

What commercial implications follow from stewardship and antibiotic resistance trends?

Resistance and stewardship shape utilization in two ways:

• Positive: when resistance rises, clinicians seek effective agents and may trial newer options.
• Negative: when stewardship tightens restrictions, broad use shrinks and new antibiotics can be constrained.

For XERAVA, gains are likely when it fits into a stewardship-approved pathway where clinicians need reliable coverage for cIAI.

How should investors model XERAVA revenue at risk from generic launch scenarios?

A practical revenue-risk model for XERAVA should incorporate:

• probability-weighted launch timing based on Orange Book and litigation posture
• speed of formulary switching after approval
• net price erosion versus list price changes
• contract conversion cycles at hospital systems

Generic launch “speed” is the biggest driver

Even with approval, uptake depends on:

• purchasing contracts
• tender cycles
• pharmacy substitution policies
• stewardship approvals for the generic substitute

Key Takeaways

• XERAVA’s market dynamics are dominated by inpatient formulary access and stewardship-driven utilization for cIAI, not broad outpatient demand.
• Pricing and contracting pressure in hospital antibiotics typically compress net revenue over time, especially when the branded drug is restricted on formularies.
• Financial trajectory is highly sensitive to competitive switching from entrenched agents like carbapenems and tigecycline and to whether XERAVA expands within hospital order sets.
• Generic entry risk is primarily governed by Orange Book-listed patents and any patent litigation or Paragraph IV challenges tied to eravacycline.
• Revenue at risk should be modeled around approval timing, expected formulary switching speed, and net price erosion rather than list-price assumptions.

FAQs

1. What factors determine whether hospitals adopt XERAVA for complicated intra-abdominal infections instead of carbapenems?
2. How do GPO contracts and hospital rebate structures typically affect net revenue for IV antibiotics like eravacycline?
3. What does the earliest-expiring listed Orange Book patent for XERAVA usually indicate for generic launch timing?
4. Do Paragraph IV settlements for eravacycline typically delay market entry, and how can that change revenue projections?
5. What labeling or stewardship pathway changes most influence year-over-year utilization of XERAVA?

References

1. FDA, “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
2. FDA, “Drug Approval Reports.” U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-databases
3. Centers for Medicare & Medicaid Services (CMS), “NDC and Drug Pricing/ASP Methodology.” U.S. Department of Health & Human Services. https://www.cms.gov/
4. FDA, “Complicated Intra-Abdominal Infections.” U.S. Food and Drug Administration (clinical/labeling resources). https://www.fda.gov/