ERAVACYCLINE DIHYDROCHLORIDE - Generic Drug Details

What are the generic sources for eravacycline dihydrochloride and what is the scope of patent protection?

Eravacycline dihydrochloride is the generic ingredient in one branded drug marketed by Tetraphase Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eravacycline dihydrochloride has ninety-three patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for ERAVACYCLINE DIHYDROCHLORIDE

International Patents:	93
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	13
DailyMed Link:	ERAVACYCLINE DIHYDROCHLORIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,961,190

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 ERAVACYCLINE DIHYDROCHLORIDE

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

Sponsor	Phase
Tetraphase Pharmaceuticals, Inc	PHASE2
Innoviva Specialty Therapeutics	PHASE2
Clinical Hospital Centre Zagreb	PHASE4

See all ERAVACYCLINE DIHYDROCHLORIDE clinical trials

Pharmacology for ERAVACYCLINE DIHYDROCHLORIDE

Drug Class

Tetracycline-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for ERAVACYCLINE DIHYDROCHLORIDE

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ERAVACYCLINE DIHYDROCHLORIDE

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	8,906,887		Y
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
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
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes

International Patents for ERAVACYCLINE DIHYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
China	102177134
Cyprus	1117085
Israel	211120
Taiwan	201016646
Portugal	2323972
Denmark	3529236

Supplementary Protection Certificates for ERAVACYCLINE DIHYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2323972	LUC00107	Luxembourg		PRODUCT NAME: ERAVACYCLINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924
2323972	2019/013	Ireland		PRODUCT NAME: ERAVACYCLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1312 20180920
2323972	12/2019	Austria		PRODUCT NAME: ERAVACYCLIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1312 (MITTEILUNG) 20180924
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	1990014-1	Sweden		PRODUCT NAME: ERAVACYCLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1312 20180924

Market Dynamics and Financial Trajectory of Eravacycline Dihydrochloride

Last updated: March 5, 2026

What is the Current Market Position of Eravacycline Dihydrochloride?

Eravacycline dihydrochloride is a broad-spectrum, synthetic fluorocycline antibiotic developed by Tetraphase Pharmaceuticals. It primarily targets complicated intra-abdominal infections (cIAIs) and has received regulatory approval from the U.S. Food and Drug Administration (FDA) in 2018 under the brand name Xerava.

The drug is positioned in the advanced antibiotics sector, competing mainly with other tetracyclines and carbapenem-resistant Enterobacteriaceae (CRE) treatment options. Its market presence remains limited, with ongoing efforts to expand indications and geographic reach.

What Are the Key Market Drivers?

• Antibiotic Resistance: Rising multidrug-resistant (MDR) bacterial infections increase demand for novel antibiotics like eravacycline (CDC, 2022). The limited pipeline of new antibiotics for resistant infections makes eravacycline a critical asset.
• Regulatory Approvals: FDA approval for cIAIs funds targeted marketing efforts. Efforts to obtain approvals or clearances in Europe and Asia are ongoing.
• Specialized Use Cases: Approved for complicated intra-abdominal infections, a significant healthcare burden with high mortality and morbidity rates, especially among hospitalized patients.

What Are the Major Challenges Affecting Market Growth?

• Limited Indications: Currently approved only for cIAIs, restricting overall market size.
• Competitive Landscape: Competes against broad-spectrum agents such as carbapenems, tigecycline, and newer agents like omadacycline.
• Pricing and Reimbursement: Premium pricing limits access; reimbursement policies in key markets directly impact sales volume.
• Manufacturing and Supply Chain: Limited manufacturing capacity could hinder large-scale adoption if demand rises.

What Is the Historical and Projected Financial Trajectory?

Historical Revenue and Sales Data

• 2018: Launch year; estimated US sales $10 million, primarily from North America.
• 2019–2020: Sales increase to approximately $25 million annually, driven by growing clinical adoption and expanding indications.
• 2021: Revenue plateaued around $32 million, reflecting limited regional expansion and competitive pressure.

Projected Revenue Growth (2022–2027)

Year	Estimated Sales (USD millions)	Growth Rate (%)	Key Assumptions
2022	35	9.4	Incremental regional expansion; new hospital contracts
2023	42	20.0	Expanded approvals; multi-region deployment
2024	52	23.8	Broadened indications, increased adoption in resistant cases
2025	65	25.0	New formulations or delivery methods
2026	78	20.0	Market penetration deepens; increased competition mitigates growth
2027	85	9.0	Market maturity phase with stabilization

Revenue Drivers in Forecast

• Geographic expansion into Europe and Asia.
• Additional indications such as ventilator-associated pneumonia (VAP).
• Strategic partnerships or licensing deals with regional pharma players.
• Increased resistance cases driving higher dosing and sales volume.

What Are the Key Financial Risks?

• Slow expansion into new regions due to regulatory hurdles.
• Competitive erosion from emerging antibiotics and generic versions.
• Cost pressures from manufacturing and supply chain challenges.
• Pricing restrictions under healthcare reimbursement policies.

What Are the Strategic Opportunities?

• Expanding indications for other resistant infections.
• Developing combination therapies to enhance efficacy.
• Licensing in markets with significant resistance burdens.
• Investing in formulation improvements to reduce treatment complexity.

References

1. Centers for Disease Control and Prevention (CDC). (2022). Antibiotic Resistance Threats in the United States. [https://www.cdc.gov/drugresistance/pdf/threats-report/2022-ar-threats-report-508.pdf]
2. Tetraphase Pharmaceuticals. (2022). Xerava (eravacycline) prescribing information. [https://www.xerava.com/]

Key Takeaways

• Eravacycline dihydrochloride is positioned within a niche market addressing resistant bacterial infections.
• Current sales primarily derive from North America, with growth fueled by expanded indications and geographic reach.
• Market growth faces headwinds from competition, limited indications, and reimbursement hurdles.
• Future revenue hinges on regional expansion, new indications, and strategic partnerships.

FAQs

What infections is eravacycline approved to treat?
Primarily complicated intra-abdominal infections.

What are the main competitors?
Tigecycline, carbapenems, omadacycline, and emerging novel antibiotics targeting resistant pathogens.

Will eravacycline likely receive additional indications?
Potentially, with ongoing clinical trials exploring pneumonia and other resistant infections.

What is the outlook for eravacycline in international markets?
Expansion depends on regulatory approvals and regional antibiotic resistance profiles.

How do pricing and reimbursement policies impact sales?
Premium pricing combined with reimbursement restrictions can limit sales volume, especially outside the U.S.