Eravacycline dihydrochloride - Generic Drug Details

What are the generic drug sources for eravacycline dihydrochloride and what is the scope of freedom to operate?

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

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
Innoviva Specialty Therapeutics	PHASE2
Tetraphase Pharmaceuticals, Inc	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	211109-002	Jun 3, 2020		RX	Yes	Yes
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-001	Aug 27, 2018		RX	Yes	Yes				Y
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-001	Aug 27, 2018		RX	Yes	Yes			Y
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes			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

International Patents for eravacycline dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	7492335
Croatia	P20130928
Croatia	P20151368
Cyprus	2019011
South Korea	20240058958
Japan	5690957

Supplementary Protection Certificates for eravacycline dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2323972	19C1012	France		PRODUCT NAME: ERAVACYCLINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1312 20180924
2323972	715	Finland
2323972	132019000000039	Italy		PRODUCT NAME: ERAVACICLINA DICLORIDRATO(XERAVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1312, 20180924
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	12/2019	Austria		PRODUCT NAME: ERAVACYCLIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1312 (MITTEILUNG) 20180924

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Eravacycline Dihydrochloride

Last updated: July 28, 2025

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Introduction

Eravacycline dihydrochloride, a broad-spectrum fluorocycline antibiotic, has garnered attention within the pharmaceutical sector due to its promising antimicrobial efficacy, particularly against multi-drug resistant pathogens. Originally developed by Tetraphase Pharmaceuticals, its potential position in combating resistant infections has influenced its market prospects and financial trajectory. This analysis explores the current market dynamics, strategic factors influencing growth, competitive landscape, regulatory environment, and future financial projections for eravacycline dihydrochloride.

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Pharmacological Profile and Clinical Development

Eravacycline belongs to the tetracycline class but features enhanced potency due to its unique chemical modifications. Approved by the U.S. Food and Drug Administration (FDA) in 2018 under the brand name Xerava, it primarily targets complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs). Its broad-spectrum activity, including efficacy against carbapenem-resistant Enterobacteriaceae (CRE), positions it as a critical asset amid rising antimicrobial resistance (AMR) concerns.

The drug's clinical development process involved comprehensive trials demonstrating non-inferiority to existing therapies, which helped facilitate regulatory approval. However, its niche positioning in a competitive antimicrobial market impacts its sales volume and revenue potential.

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Market Dynamics

1. Growing Antimicrobial Resistance (AMR) and Unmet Medical Needs

The increasing prevalence of multidrug-resistant bacteria, notably CRE, Pseudomonas aeruginosa, and Acinetobacter baumannii, fuels demand for new antibiotics like eravacycline [1]. Global health initiatives and regulatory agencies emphasize the urgent need for antibiotics with novel mechanisms to combat AMR, thus creating a conducive environment for eravacycline’s adoption.

2. Therapeutic Niche and Limitations

Despite its broad activity, eravacycline faces limitations including competition from established antibiotics such as carbapenems, tigecycline, and newer agents like plazomicin. Its market penetration depends on demonstrating superior efficacy, safety, and resistance profiles. Additionally, the focus on cIAIs and cUTIs confines its addressable market size, which, although significant, is segmented.

3. Competitive Landscape

Eravacycline competes with both traditional tetracyclines and newer antibiotic classes. Key competitors include tigecycline (Tygacil), minocycline, and emerging antibiotics targeting resistant infections. Market success hinges on differentiating factors like spectrum of activity, side-effect profiles, and ease of use.

4. Regulatory and Reimbursement Environment

The drug’s FDA approval grants a regulatory advantage, but its market expansion in Europe and other regions depends on local approvals and reimbursement policies. Pricing strategies, distribution channels, and healthcare provider acceptance influence its sales trajectory. The high cost common in novel antibiotics often constrains access and sales volumes.

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Financial Trajectory

1. Revenue Performance and Growth Potential

Initially, eravacycline's sales experienced modest growth owing to restricted indications and limited commercialization. According to financial disclosures, in 2020, Xerava generated approximately $33 million in U.S. sales, reflecting cautious market penetration. For 2021 and beyond, growth prospects rely on expanded clinical indications, increased formulary adoption, and geographic expansion [2].

2. Market Penetration Strategies

Tetraphase Pharmaceuticals, the original manufacturer, adopted proactive strategies including clinical data generation, collaborations with global health agencies, and targeted marketing to infection specialists. In 2019, the company licensed Xerava’s commercialization rights outside the U.S. to Zai Lab and Everest Medicines, which expanded distribution in China and other markets, potentially boosting revenues significantly.

3. Investment and R&D Outlook

Future revenue growth depends on ongoing R&D investment, including development of combination therapies, new indications, and potential formulation improvements. Efforts to demonstrate efficacy against resistant strains and reduced side-effect profiles will be pivotal.

4. Market Entry Barriers and Cost Dynamics

High manufacturing costs, complex procurement processes, and antimicrobial stewardship programs impose barriers to widespread adoption. These factors, alongside pricing pressures and stewardship efforts to mitigate resistance, suppress rapid revenue scaling.

5. Financial Risks and Opportunities

Significant risks include slow uptake, resistance development diminishing efficacy, and regulatory delays in new markets or indications. Conversely, increasing antibiotic resistance and the crowded pipeline of novel antimicrobials present opportunities for eravacycline if positioned effectively as a first-line or salvage therapy.

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Regulatory and Patent Landscape

The patent protection for eravacycline extends into the early 2030s, offering a window for exclusive sales and pricing power. However, generic competitors could potentially threaten profitability post-patent expiry, emphasizing the need for strategic lifecycle management.

Additionally, regulatory agencies’ emphasis on antimicrobial stewardship and restrictions on pricing of antibiotics may temper revenue growth, even with clinical acceptance.

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Market Forecast and Future Financial Trajectory

Analysts project that eravacycline's global sales could reach $200–$400 million annually within the next 5 years, contingent on expanding indications, geographic growth, and clinician adoption. The growth rate will be influenced by the evolving landscape of antimicrobial resistance, payer reimbursement policies, and competitive dynamics.

Accelerating adoption could be facilitated through strategic collaborations, aggressive evidence generation, and inclusion in treatment guidelines. The commercialization success outside the U.S.—especially in China—holds substantial potential, given the high burden of resistant infections and rising antibiotic demand.

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Key Market Drivers

• Rising global AMR necessitating novel treatments.
• Regulatory approval in multiple jurisdictions.
• Strategic licensing and partnerships expanding geographic reach.
• Investment in clinical trials for additional indications.
• Growing healthcare expenditure and infection management programs.

Critical Challenges

• Competition from existing and pipeline antibiotics.
• High development and production costs.
• Pricing pressures and antimicrobial stewardship efforts.
• Limited indications constraining market size.
• Risk of resistance development diminishing efficacy.

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Key Takeaways

• Eravacycline dihydrochloride is positioned in a niche market addressing critical unmet needs posed by antimicrobial resistance.
• Revenue growth hinges on expanding clinical indications, geographic markets, and clinician adoption.
• Strategic collaborations outside the U.S. are vital for scaling revenues, with China representing significant upside.
• Competitive dynamics and stewardship policies could constrain short-term growth; long-term success requires differentiation and evidence-based positioning.
• The patent landscape affords a limited window for exclusive commercialization, emphasizing the importance of lifecycle planning.

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FAQs

1. What are the primary clinical indications for eravacycline dihydrochloride?
Eravacycline is approved for complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs), particularly those caused by multi-drug resistant bacteria.

2. How does eravacycline differ from other tetracycline antibiotics?
Eravacycline features chemical modifications that improve its activity against resistant strains and reduce efflux and ribosomal protection mechanisms that typically confer resistance to traditional tetracyclines.

3. What is the current market outlook for eravacycline?
Projected global sales could reach $200–$400 million annually within five years, driven by expanding indications, regulatory approvals, and geographic penetration, especially in China.

4. Which factors could hinder eravacycline’s market growth?
Major barriers include competition from existing antibiotics, high treatment costs, restrictive antimicrobial stewardship policies, and potential resistance development.

5. How does the patent landscape impact eravacycline’s financial potential?
The patent protection lasts into the early 2030s, offering a period of market exclusivity that supports pricing and revenue, but generic entry thereafter could significantly reduce profitability.

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References

[1] World Health Organization. (2019). Global antimicrobial resistance surveillance system (GLASS).
[2] Tetraphase Pharmaceuticals. (2021). Annual Report.