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Last Updated: January 18, 2020

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VIBATIV Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Vibativ

  Start Trial

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

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

Drug patent expirations by year for VIBATIV
Drug Prices for VIBATIV

See drug prices for VIBATIV

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
Theravance Biopharma, US, Inc.Phase 4
Joseph KutiPhase 4
Theravance Biopharma Antibiotics, Inc.Phase 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

Pharmacology for VIBATIV
Synonyms for VIBATIV
0701472ZG0
372151-71-8
560130-42-9
AC1MIWRX
CHEBI:71226
CHEBI:71229
CHEMBL3301680
CHEMBL507870
D06057
DB06402
HSDB 8194
LS-192933
N(3'')-[2-(decylamino)ethyl]-29-{[(phosphonomethyl)amino]methyl}vancomycin
SCHEMBL8287015
T-1455
Td 6424
TD-6424
Telavancin
Telavancin [INN]
Telavancin HCl
Telavancin Hydrochloride
Telavancin hydrochloride (USAN)
Telavancin hydrochloride [USAN]
Telavancin, Antibiotic for Culture Media Use Only
telavancina
telavancine
telavancinum
UNII-0701472ZG0
UNII-XK134822Z0
Vancomycin, N3'-(2-(decylamino)ethyl)-29-(((phosphonomethyl)amino)methyl)-, monohydrochloride
Vancomycin, N3''-(2-(decylamino)ethyl)-29-(((phosphonomethyl)amino)methyl)-
Vibativ (TN)
XK134822Z0

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
>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 2011C/045 Belgium   Start Trial PRODUCT NAME: VIBATIV - TELAVANCINE; AUTHORISATION NUMBER AND DATE: EU/1/11/705-001 20110902
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 91908 Luxembourg   Start Trial 91908, EXPIRES: 20260501
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
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AstraZeneca
Colorcon
Merck
Mallinckrodt

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