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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 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

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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:	102
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for xerava

Generic Entry Date for xerava^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of xerava is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

C7-fluoro substituted tetracycline compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN PATIENTS 18 YEARS OF AGE AND OLDER

C7-fluoro substituted tetracycline compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting xerava

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-001	Aug 27, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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
Patent: 艾若威四环素的结晶形式 (CRYSTALLINE FORMS OF ERAVACYCLINE)
Estimated Expiration: ⤷ Sign Up

Patent: 7903083
Patent: 艾若威四环素的结晶形式
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 29236
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 29236
Patent: FORMES CRISTALLINES DE L'ÉRAVACYCLINE (CRYSTALLINE FORMS OF ERAVACYCLINE)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 19531321
Patent: エラバサイクリンの結晶形
Estimated Expiration: ⤷ Sign Up

Patent: 22186979
Patent: エラバサイクリンの結晶形
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 567
Patent: FORMES CRISTALLINES DE L'ÉRAVACYCLINE
Estimated Expiration: ⤷ Sign Up

Philippines

Patent: 019500822
Patent: CRYSTALLINE FORMS OF ERAVACYCLINE
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201903327P
Patent: CRYSTALLINE FORMS OF ERAVACYCLINE
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2660864
Estimated Expiration: ⤷ Sign Up

Patent: 190065414
Patent: 에라바사이클린의 결정질 형태
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
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	⤷ Sign Up
Singapore	11201903327P	CRYSTALLINE FORMS OF ERAVACYCLINE	⤷ Sign Up
New Zealand	591051	C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS	⤷ Sign Up
Lithuania	C2323972		⤷ Sign Up
Netherlands	300971		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for xerava

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2323972	132019000000039	Italy	⤷ Sign Up	PRODUCT NAME: ERAVACICLINA DICLORIDRATO(XERAVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1312, 20180924
2323972	CR 2019 00009	Denmark	⤷ Sign Up	PRODUCT NAME: ERAVACYCLIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1312 20180209
2323972	2019C/511	Belgium	⤷ Sign Up	PRODUCT NAME: ERAVACYCLINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924
2323972	LUC00107	Luxembourg	⤷ Sign Up	PRODUCT NAME: ERAVACYCLINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924
2323972	2019010	Norway	⤷ Sign Up	PRODUCT NAME: ERAVASYKLIN ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/18/1312 20181025
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description