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 eighty-four patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for eravacycline dihydrochloride

International Patents:	84
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	11
Patent Applications:	4
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
West Virginia University	Phase 2
Tetraphase Pharmaceuticals, Inc.	Phase 3
Tetraphase Pharmaceuticals, Inc.	Phase 1

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

International Patents for eravacycline dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Portugal	2323972
Spain	2430254
Japan	2011530534

Supplementary Protection Certificates for eravacycline dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2323972	132019000000039	Italy		PRODUCT NAME: ERAVACICLINA DICLORIDRATO(XERAVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1312, 20180924
2323972	CR 2019 00009	Denmark		PRODUCT NAME: ERAVACYCLIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1312 20180209
2323972	PA2019009	Lithuania		PRODUCT NAME: ERAVACIKLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1312 C(2018)6231 20180920

Eravacycline dihydrochloride Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Eravacycline Dihydrochloride

Introduction

Eravacycline dihydrochloride, marketed under the brand name Xerava, is a novel antimicrobial drug developed to combat serious bacterial infections. This article delves into the market dynamics and financial trajectory of eravacycline, highlighting its development costs, market performance, and the broader context of the antimicrobial drugs market.

Development and Approval Costs

The development and approval of eravacycline dihydrochloride are associated with significant costs. According to the Antimicrobial Drugs Market Returns Analysis, the estimated development and approval cost for Xerava was approximately $182.7 million in 2018 dollars[4].

When considering the capitalized costs, which include the cost of failures and the opportunity cost of capital, the figure rises to $1,471.4 million in 2018 dollars. This is relatively lower compared to other drug cohorts, such as oncology drugs, which have much higher capitalized development and approval costs[1].

Clinical Value and Comparative Benefit

Eravacycline dihydrochloride has been evaluated for its clinical value using various metrics, including the Overall Clinical Value Score. With European Health Technology Assessment (HTA) scores, Xerava's clinical value score is 209, and without HTA scores, it is 146. These scores indicate the drug's comparative added clinical benefit relative to other treatments for similar indications[4].

Market Performance

The market performance of Xerava is measured by its cumulative global sales since its market launch. According to the IQVIA MIDAS data, the first nine quarters of sales for Xerava amounted to $12.79 million in 2018 dollars. This figure is modest compared to the sales of oncology drugs but aligns with the general trend that antimicrobial drugs tend to have lower sales volumes due to their conservative use to prevent resistance[1][4].

Sales vs. Clinical Benefit

There is a correlation between the comparative added clinical benefit of a drug and its early market sales. Drugs with higher clinical benefit scores tend to have higher sales, although this relationship is more pronounced in the oncology cohort. For antimicrobial drugs like Xerava, the sales are significantly lower but still reflect the drug's clinical value[1].

Market Dynamics of Antimicrobial Drugs

The antimicrobial drugs market is characterized by growing demand, particularly in low- and middle-income countries (LMICs), but it is also marked by low profit margins and high development risks. The market is expected to grow to $55.8 billion by 2023, up from $38.3 billion in 2018, driven by increasing generic antibacterial demand[3].

However, the development of new antimicrobials is challenging due to the evolutionary arms race between pathogens and medicines, leading to resistance. This has resulted in a drying up of the global antibacterial pipeline, with only 15 new antibacterials approved since 2000, compared to 63 between 1980 and 2000[3].

Incentives for Antimicrobial R&D

To incentivize the development of new antimicrobial medicines, various "push" and "pull" mechanisms have been implemented. Push incentives include research grants, tax incentives, and public-private partnerships, while pull mechanisms involve guarantees of revenue through extended market exclusivity, accelerated regulatory pathways, or premium pricing. For example, the Generating Antibiotic Incentives Now (GAIN) Act in the United States grants an additional five years of market exclusivity to companies developing new antibacterials[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of antimicrobial drugs. The FDA's guidance and approval processes are critical for bringing new drugs like Xerava to the market. The FDA's current thinking on eravacycline dihydrochloride is outlined in their draft guidance, which reflects the agency's approach to ensuring the safety and efficacy of antimicrobial treatments[5].

Competitive Landscape

The competitive landscape for antimicrobial drugs is complex, with both large pharmaceutical companies and smaller biopharmaceutical firms involved. While some large companies have reduced their involvement in antimicrobial R&D due to low profit margins, a core group of companies remains committed to this area. Smaller biopharmaceutical companies are also increasingly focused on antimicrobial R&D, driven by the urgent need for new treatments[3].

Future Outlook

The future outlook for eravacycline dihydrochloride and other antimicrobial drugs is influenced by the ongoing battle against antimicrobial resistance (AMR). The need for new products is urgent, and the market is expected to continue growing, albeit with challenges related to resistance and low profit margins. Incentives and regulatory support will be crucial in sustaining R&D efforts in this critical therapeutic area.

Key Takeaways

• Development Costs: Eravacycline dihydrochloride had an estimated development and approval cost of $182.7 million and a capitalized cost of $1,471.4 million.
• Clinical Value: The drug has a significant clinical value score, indicating its comparative added benefit.
• Market Performance: Sales for Xerava are modest, reflecting the general trend for antimicrobial drugs.
• Market Dynamics: The antimicrobial market is growing but faces challenges such as low profit margins and resistance.
• Incentives: Various push and pull mechanisms are in place to incentivize R&D in antimicrobials.
• Regulatory Environment: FDA guidance is crucial for the approval and market entry of new antimicrobials.

FAQs

What is the estimated development and approval cost for eravacycline dihydrochloride?

The estimated development and approval cost for eravacycline dihydrochloride was approximately $182.7 million in 2018 dollars[4].

How does the market performance of Xerava compare to other drug cohorts?

The market performance of Xerava, measured by its first nine quarters of sales, is significantly lower than that of oncology drugs but aligns with the general trend for antimicrobial drugs[1][4].

What are the main challenges in the development of new antimicrobial drugs?

The main challenges include low profit margins, high development risks, and the need to develop new products at a rate that matches the emergence of resistance[3].

What incentives are available to encourage the development of new antimicrobial drugs?

Incentives include push mechanisms like research grants and tax incentives, as well as pull mechanisms such as extended market exclusivity and premium pricing[3].

How does the regulatory environment impact the market entry of new antimicrobial drugs?

The FDA's guidance and approval processes are critical for ensuring the safety and efficacy of new antimicrobial treatments, influencing their market entry and success[5].

Sources

1. Antimicrobial Drugs Market Returns Analysis - ASPE
2. Eravacycline dihydrochloride - MedchemExpress.com
3. Antimicrobial Resistance Benchmark 2020 - Access to Medicine Foundation
4. Xerava (eravacycline) Information - NCBI
5. Eravacycline dihydrochloride - FDA.gov