VIBATIV Drug Patent Profile

When do Vibativ patents expire, and what generic alternatives are available?

Vibativ is a drug marketed by Cumberland Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and twenty-eight patent family members in thirty-five countries.

The generic ingredient in VIBATIV is telavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the telavancin hydrochloride profile page.

DrugPatentWatch^® 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

Summary for VIBATIV

International Patents:	128
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	13
Patent Applications:	11
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIBATIV
What excipients (inactive ingredients) are in VIBATIV?	VIBATIV excipients list
DailyMed Link:	VIBATIV at DailyMed

See drug prices for VIBATIV

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

NDA:

022110

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

Sponsor	Phase
Cumberland Pharmaceuticals, Inc.	Phase 4
Joseph Kuti	Phase 4
Theravance Biopharma, US, Inc.	Phase 4

See all VIBATIV clinical trials

Pharmacology for VIBATIV

Drug Class

Lipoglycopeptide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for VIBATIV

J01XA	Glycopeptide antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for VIBATIV

VIBATIV is protected by three US patents.

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 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			Y	Y
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009		RX	Yes	Yes			Y	Y
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009		DISCN	Yes	No			Y
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009		DISCN	Yes	No				Y
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009		RX	Yes	Yes			Y
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009		RX	Yes	Yes				Y

Expired US Patents for VIBATIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009
Cumberland Pharms	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009

International Patents for VIBATIV

When does loss-of-exclusivity occur for VIBATIV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Mexico

Poland

Portugal

Slovenia

South Korea

Spain

Taiwan

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 VIBATIV around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2408008	COMPOSITIONS PHARMACEUTIQUES CONTENANT UN ANTIBIOTIQUE GLYCOPEPTIDIQUE ET UNE CYCLODEXTRINE (PHARMACEUTICAL COMPOSITIONS CONTAINING A GLYCOPEPTIDE ANTIBIOTIC AND A CYCLODEXTRIN)
Denmark	2495251
South Korea	101166250
South Africa	200209419	Glycopeptide phosphonate derivatives.
Australia	5929801
European Patent Office	1278549	COMPOSITION CONTENANT UNE CYCLODEXTRINE ET UN ANTIBIOTIQUE GYLCOPEPTIDIQUE (COMPOSITION CONTAINING A CYCLODEXTRIN AND A GLYCOPEPTIDE ANTIBIOTIC)
Cyprus	1113773

Supplementary Protection Certificates for VIBATIV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1292612	SPC/GB11/056	United Kingdom		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
1292612	PA2012002	Lithuania		PRODUCT NAME: TELAVANCINUM; REGISTRATION NO/DATE: EU/1/11/705/001, 2011 09 02 EU/1/11/705/002 20110902
1292612	132012902025885	Italy		PRODUCT NAME: TELAVANCINA(VIBATIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/705/001-002, 20110902
1292612	PA2012002,C1292612	Lithuania		PRODUCT NAME: TELAVANCINUM; REGISTRATION NO/DATE: EU/1/11/705/001, 2011 09 02 EU/1/11/705/002 20110902
1292612	C300507	Netherlands		PRODUCT NAME: TELAVANCINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, INCLUSIEF TELAVANCINE HYDROCLORIDE; REGISTRATION NO/DATE: EU/1/11/705/001 - 002 20110902
1292612	2011C/045	Belgium		PRODUCT NAME: VIBATIV - TELAVANCINE; AUTHORISATION NUMBER AND DATE: EU/1/11/705-001 20110902
1292612	C 2012 002	Romania		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