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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 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:	80
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	1
Patent Applications:	120
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

Anatomical Therapeutic Chemical (ATC) Classes for XERAVA

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

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.

Patents protecting XERAVA

FDA Regulatory Exclusivity protecting XERAVA

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

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
New Zealand	603568	C7-fluoro substituted tetracycline compounds
Canada	2732883	COMPOSES DE TETRACYCLINE C7-FLUOROSUBSTITUEE (C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS)
Israel	211120	תרכובת, טטראציקלין מותמרת בעמדה 7c עם פלואור, תכשיר רוקחות המכיל אותה ושימוש בה להכנת תרופות לטיפול בזיהום הנגרם על ידי בקטריה (C7-fluoro substituted tetracycline compound, pharmaceutical composition comprising it and its use in the manufacture of medicaments for treating infection caused by bacteria)
Serbia	54485	C7-FLUORO SUPSTITUISANA TETRACIKLINSKA JEDINJENJA (C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS)
South Korea	20110058800	C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS
Hong Kong	1193412	-氟取代的四環素化合物 (C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS C7-)
South Korea	101679023

Supplementary Protection Certificates for XERAVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2323972	CA 2019 00009	Denmark		PRODUCT NAME: ERAVACYCLIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1312 20180209
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	C20190009 00277	Estonia		PRODUCT NAME: ERAVATSUEKLIIN;REG NO/DATE: EU/1/18/1312 24.09.2018
2323972	CR 2019 00009	Denmark		PRODUCT NAME: ERAVACYCLIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1312 20180209
2323972	LUC00107	Luxembourg		PRODUCT NAME: ERAVACYCLINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924
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