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Last Updated: May 19, 2022

XERAVA Drug Patent Profile


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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 three patents protecting this drug.

This drug has seventy-eight patent family members in thirty-two countries.

The generic ingredient in XERAVA is eravacycline dihydrochloride. Additional details are available on the eravacycline dihydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Xerava

Xerava will be eligible for patent challenges on August 27, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

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Summary for XERAVA
International Patents:78
US Patents:3
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 23
Patent Applications: 125
Drug Prices: Drug price information for XERAVA
What excipients (inactive ingredients) are in XERAVA?XERAVA excipients list
DailyMed Link:XERAVA at DailyMed
Drug patent expirations by year for XERAVA
Drug Prices for XERAVA

See drug prices for XERAVA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for XERAVA
Generic Entry Date for XERAVA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for XERAVA

XERAVA is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XERAVA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XERAVA

Crystalline forms of eravacycline
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

C7-fluoro substituted tetracycline compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN PATIENTS 18 YEARS OF AGE AND OLDER

C7-fluoro substituted tetracycline compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XERAVA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tetraphase Pharms XERAVA eravacycline dihydrochloride POWDER;INTRAVENOUS 211109-002 Jun 3, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Tetraphase Pharms XERAVA eravacycline dihydrochloride POWDER;INTRAVENOUS 211109-001 Aug 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tetraphase Pharms XERAVA eravacycline dihydrochloride POWDER;INTRAVENOUS 211109-002 Jun 3, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 0582486
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 29236
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19531321
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 567
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 019500822
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201903327P
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 190065414
Estimated Expiration: See Plans and Pricing

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
Japan 2014148509 C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS See Plans and Pricing
Singapore 10201806714P C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS See Plans and Pricing
South Korea 20110058800 C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS See Plans and Pricing
Brazil PI0916985 composto de tetraciclina c7-fluoro substituído, composição farmacêutica que o compreende e método para o tratamento ou prevenção de uma infecção ou colonização em um paciente See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XERAVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2323972 2019/013 Ireland See Plans and Pricing PRODUCT NAME: ERAVACYCLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1312 20180920
2323972 PA2019009 Lithuania See Plans and Pricing PRODUCT NAME: ERAVACIKLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1312 C(2018)6231 20180920
2323972 2019C/511 Belgium See Plans and Pricing PRODUCT NAME: ERAVACYCLINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924
2323972 122019000024 Germany See Plans and Pricing PRODUCT NAME: ERAVACYCLINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1312 20180920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Express Scripts
Dow
Moodys
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.