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VIBATIV Drug Profile
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» See Plans and PricingWhen 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 eleven 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. Additional details are available on the telavancin hydrochloride profile page.
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
Summary for VIBATIV
| International Patents: | 128 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 5 |
| Clinical Trials: | 13 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VIBATIV |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VIBATIV |
| DailyMed Link: | VIBATIV at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Joseph Kuti | Phase 4 |
| Theravance Biopharma, US, Inc. | Phase 4 |
| University of Illinois at Chicago | Phase 1 |
Recent Litigation for VIBATIV
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| THERAVANCE, INC. v. KAPPOS | 2009-11-04 |
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 |
International Patents for VIBATIV
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 0110530 | Start Trial |
| Germany | 122011100062 | Start Trial |
| Canada | 2408008 | Start Trial |
| Norway | 330134 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0183520 | Start Trial |
| China | 1223378 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
