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Last Updated: March 29, 2020

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VIBATIV Drug Profile


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US ANDA Litigation and Generic Entry Outlook for Vibativ

Vibativ was eligible for patent challenges on September 11, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 1, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for VIBATIV
Drug Prices for VIBATIV

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Generic Entry Opportunity Date for VIBATIV
Generic Entry Date for VIBATIV*:
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.

Recent Clinical Trials for VIBATIV

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

SponsorPhase
Joseph KutiPhase 4
Theravance Biopharma, US, Inc.Phase 4
University of Illinois at ChicagoPhase 1

See all VIBATIV clinical trials

Recent Litigation for VIBATIV

Identify potential future generic entrants

District Court Litigation
Case NameDate
THERAVANCE, INC. v. KAPPOS2009-11-04

See all VIBATIV litigation

Synonyms for VIBATIV
0701472ZG0
560130-42-9
CHEBI:71226
CHEMBL3301680
D06057
Q47495786
Td 6424
TD-6424
Telavancin HCl
Telavancin Hydrochloride
Telavancin hydrochloride (USAN)
Telavancin hydrochloride [USAN]
UNII-0701472ZG0
Vancomycin, N3'-(2-(decylamino)ethyl)-29-(((phosphonomethyl)amino)methyl)-, monohydrochloride
Vibativ (TN)

US Patents and Regulatory Information for VIBATIV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cumberland Pharms VIBATIV telavancin hydrochloride POWDER;INTRAVENOUS 022110-001 Sep 11, 2009 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Cumberland Pharms VIBATIV telavancin hydrochloride POWDER;INTRAVENOUS 022110-002 Sep 11, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cumberland Pharms VIBATIV telavancin hydrochloride POWDER;INTRAVENOUS 022110-001 Sep 11, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Cumberland Pharms VIBATIV telavancin hydrochloride POWDER;INTRAVENOUS 022110-001 Sep 11, 2009 DISCN Yes No   Start Trial   Start Trial   Start Trial
Cumberland Pharms VIBATIV telavancin hydrochloride POWDER;INTRAVENOUS 022110-002 Sep 11, 2009 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Cumberland Pharms VIBATIV telavancin hydrochloride POWDER;INTRAVENOUS 022110-002 Sep 11, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VIBATIV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1292612 C 2012 002 Romania   Start Trial PRODUCT NAME: TELAVANCIN SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIAINCLUZAND CLORHIDRAT DE TELAVANCIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/705/001, RO EU/1/11/705/002; DATE OF NATIONAL AUTHORISATION: 20110902; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/705/001, EU/1/11/705/002; DATE OF FIRST AUTHORISATION IN EEA: 20110902
1292612 36/2011 Austria   Start Trial PRODUCT NAME: TELAVANCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIEVON, EINSCHLIESSLICH TELAVANCINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/705/001-002 20110902
1292612 417 Finland   Start Trial
1292612 C300507 Netherlands   Start Trial PRODUCT NAME: TELAVANCINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, INCLUSIEF TELAVANCINE HYDROCLORIDE; REGISTRATION NO/DATE: EU/1/11/705/001 - 002 20110902
1292612 132012902025885 Italy   Start Trial PRODUCT NAME: TELAVANCINA(VIBATIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/705/001-002, 20110902
1292612 SPC/GB11/056 United Kingdom   Start Trial PRODUCT NAME: TELAVANCIN, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TELAVANCIN HYDROCHLORIDE; REGISTERED: UK EU/1/11/705/001 20110906; UK EU/1/11/705/002 20110906
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Johnson and Johnson
Medtronic
Merck
AstraZeneca

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.