Eravacycline dihydrochloride - Generic Drug Details

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What are the generic drug sources for eravacycline dihydrochloride and what is the scope of freedom to operate?

Eravacycline dihydrochloride is the generic ingredient in one branded drug marketed by Tetraphase Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eravacycline dihydrochloride has eighty-four patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for eravacycline dihydrochloride

International Patents:	84
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	11
Patent Applications:	4
DailyMed Link:	eravacycline dihydrochloride at DailyMed

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

Generic Entry Date for eravacycline dihydrochloride^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 eravacycline dihydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
West Virginia University	Phase 2
Tetraphase Pharmaceuticals, Inc.	Phase 3
Tetraphase Pharmaceuticals, Inc.	Phase 1

See all eravacycline dihydrochloride clinical trials

Pharmacology for eravacycline dihydrochloride

Drug Class	Tetracycline-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for eravacycline dihydrochloride

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

US Patents and Regulatory Information for eravacycline dihydrochloride

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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	Y			⤷ Sign Up
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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		Y		⤷ Sign Up
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-002	Jun 3, 2020		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
>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 eravacycline dihydrochloride

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Country	Patent Number	Title	Estimated Expiration
Australia	2009279473	C7-fluoro substituted tetracycline compounds	⤷ Sign Up
Denmark	3529236		⤷ Sign Up
Serbia	53003	C7-FLUORO SUPSTITUISANA TETRACIKLINSKA JEDINJENJA (C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS)	⤷ Sign Up
Japan	2022186979	エラバサイクリンの結晶形	⤷ Sign Up
South Korea	20170018483	Ｃ７-플루오로 치환된 테트라시클린 화합물 (- C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS)	⤷ Sign Up
Argentina	112532	COMPUESTOS DE TETRACICLINA SUSTITUIDOS CON FLÚOR EN C7	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for eravacycline dihydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	12/2019	Austria	⤷ Sign Up	PRODUCT NAME: ERAVACYCLIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1312 (MITTEILUNG) 20180924
2323972	SPC/GB19/017	United Kingdom	⤷ Sign Up	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	PA2019009	Lithuania	⤷ Sign Up	PRODUCT NAME: ERAVACIKLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1312 C(2018)6231 20180920
2323972	PA2019009,C2323972	Lithuania	⤷ Sign Up	PRODUCT NAME: ERAVACIKLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1312 C(2018)6231 20180920
2323972	C20190009 00277	Estonia	⤷ Sign Up	PRODUCT NAME: ERAVATSUEKLIIN;REG NO/DATE: EU/1/18/1312 24.09.2018
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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