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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 eighty-four 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 October 19, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XERAVA

International Patents:	84
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	1
Patent Applications:	104
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

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.

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
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	211109-002	Jun 3, 2020		RX	Yes	Yes
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		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	211109-001	Aug 27, 2018		RX	Yes	Yes				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:

China

Denmark

European Patent Office

Japan

Morocco

Philippines

Singapore

South Korea

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
Portugal	2323972
Spain	2430254
Japan	2011530534
New Zealand	624272	C7-fluoro substituted tetracycline compounds
Singapore	11201903327P	CRYSTALLINE FORMS OF ERAVACYCLINE
South Korea	101679023
Spain	2558512

Supplementary Protection Certificates for XERAVA

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
2323972	LUC00107	Luxembourg		PRODUCT NAME: ERAVACYCLINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924
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	300971	Netherlands		PRODUCT NAME: ERAVACYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/18/1312 20180924
2323972	2019010	Norway		PRODUCT NAME: ERAVASYKLIN ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/18/1312 20181025

XERAVA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Xerava

Introduction

Xerava, developed by Tetraphase Pharmaceuticals and now marketed by La Jolla Pharmaceutical Company, is a tetracycline-class antibacterial drug approved for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years and older. Here, we delve into the market dynamics and financial trajectory of Xerava since its approval.

FDA Approval and Market Entry

Xerava received FDA approval on August 28, 2018, marking a significant milestone in the fight against antibiotic-resistant infections. The approval was the result of a five-year partnership with the Biomedical Advanced Research and Development Authority (BARDA), which provided funding and consultant advice[3].

Commercial Launch Strategy

Tetraphase adopted a unique commercial launch strategy for Xerava, focusing on hospital formularies and targeting tier 1 and tier 2 hospitals. The company hired 35 regional account managers to "hyper-target" approximately 700 tier 1 hospitals, aiming to secure formulary inclusion. This approach was designed to differentiate Xerava from other newly approved antibiotics, which often have limited labels and higher price points[3].

Pricing Strategy

Xerava was launched with a list price between $175 and $250, significantly lower than many other antibiotics. This pricing strategy was intended to facilitate quicker formulary inclusion and broader prescription use, particularly as a first- or second-line therapy for cIAI[3].

Market Performance

Initial Market Reception

Despite the strategic launch, the initial market reaction was mixed. Tetraphase's stock price dropped about 10% in the first hour of trading following the FDA approval, reflecting investor skepticism about the drug's commercial potential[3].

Sales Growth

However, Xerava has shown steady sales growth since its launch. For the twelve months ended December 31, 2021, Xerava U.S. net product sales were $10.1 million, a 23% increase from the same period in 2020. In the third quarter of 2021, Xerava U.S. net product sales were $2.9 million, up 26% from the third quarter of 2020[1].

Recent Financial Performance

As of the third quarter of 2024, Xerava's U.S. net product sales continued to contribute to the overall revenue of La Jolla Pharmaceutical Company. For this period, Xerava generated $2.3 million in net product sales, part of a broader portfolio that included GIAPREZA and XACDURO, which together saw a 68% increase in net product sales compared to the third quarter of 2023[2].

Financial Trajectory

Revenue and Net Income

La Jolla Pharmaceutical Company's acquisition of Tetraphase in July 2020 significantly impacted its financial performance. For the twelve months ended December 31, 2021, La Jolla's net product sales, including Xerava, were $43.5 million, up from $33.4 million in the same period in 2020. The company reported a net income of $19.7 million for 2021, a substantial improvement from the net loss of $39.4 million in 2020[1].

Operating Expenses and Cash Flow

The company's operating expenses, including selling, general, and administrative costs, as well as research and development expenses, have been managed to support the growth of Xerava and other products. As of 2021, total operating expenses were $53.9 million, down from $69.3 million in 2020. This reduction, along with increased sales, contributed to improved cash flow and net income[1].

Global Expansion

European Market

In addition to its U.S. market presence, Xerava has been making strides in Europe. A European Medicines Agency committee adopted a positive opinion on Xerava, paving the way for potential approval by the European Commission. This expansion is crucial for broadening the drug's market reach and increasing its global revenue potential[3].

Asian Markets

Xerava is also being introduced in various Asian markets through partnerships. For instance, Everest, La Jolla’s licensee, submitted a New Drug Application (NDA) in China, which was accepted by the China National Medical Products Administration (NMPA). This move is part of a broader strategy to penetrate key markets in Asia, including mainland China, Taiwan, Hong Kong, and other regions[1].

Challenges and Opportunities

Antibiotic Resistance

The market for antibiotics is challenging due to the increasing threat of antibiotic resistance. However, this also presents an opportunity for Xerava, as it offers a new treatment option for multi-drug resistant infections. The drug's broad label for cIAI treatment without the limitation of being a last resort therapy positions it favorably in the market[3].

Competitive Landscape

The antibiotic market has seen significant changes, with larger pharmaceutical companies exiting the space. This has left room for smaller biotechs like Tetraphase to fill the gap. Xerava's competitive pricing and targeted marketing strategy have helped it gain traction in a market dominated by larger players[3].

Key Takeaways

• FDA Approval and Launch: Xerava was approved by the FDA in 2018 and launched with a strategic focus on hospital formularies and tiered pricing.
• Sales Growth: Xerava has shown steady sales growth, with a 23% increase in U.S. net product sales for 2021 compared to 2020.
• Financial Performance: The acquisition by La Jolla Pharmaceutical Company has improved the financial trajectory, with increased net product sales and reduced operating expenses.
• Global Expansion: Xerava is expanding into European and Asian markets, enhancing its global revenue potential.
• Market Dynamics: The drug's competitive pricing and broad treatment label position it favorably in the antibiotic market, despite the challenges posed by antibiotic resistance.

FAQs

What is Xerava used for?

Xerava is used for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years and older.

Who developed Xerava?

Xerava was developed by Tetraphase Pharmaceuticals and is now marketed by La Jolla Pharmaceutical Company.

What was the initial market reaction to Xerava's FDA approval?

The initial market reaction was mixed, with Tetraphase's stock price dropping about 10% in the first hour of trading following the FDA approval.

How has Xerava performed in terms of sales?

Xerava has shown steady sales growth, with $10.1 million in U.S. net product sales for the twelve months ended December 31, 2021, a 23% increase from the same period in 2020.

Is Xerava available in markets outside the U.S.?

Yes, Xerava is being introduced in various markets, including Europe and Asia, through partnerships and regulatory approvals.

Sources

1. La Jolla Pharmaceutical Company Announces Financial Results for the Three and Twelve Months Ended December 31, 2021 and Highlights Corporate Progress - Business Wire
2. Innoviva Reports Third Quarter 2024 Financial Results - Business Wire
3. FDA approves Tetraphase's antibiotic Xerava - BioPharma Dive
4. Net Present Value Model: Xerava - GlobalData
5. Innoviva Reports Second Quarter 2024 Financial Results - Innoviva Investor Relations