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 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

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

See drug prices for XERAVA

DrugPatentWatch^® Estimated Generic Entry Opportunity 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.

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 three 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			Y
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				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
Japan	2014148509	C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS
Singapore	10201806714P	C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS
South Korea	20110058800	C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS
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

Supplementary Protection Certificates for XERAVA

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