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VIBATIV Drug Profile
Which patents cover Vibativ, 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-four 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.
Summary for VIBATIV
| International Patents: | 124 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 13 |
| Patent Applications: | 2 |
| 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;IV (INFUSION) |
*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 |
|---|---|
| Theravance Biopharma, US, Inc. | Phase 4 |
| Joseph Kuti | Phase 4 |
| Theravance Biopharma Antibiotics, Inc. | Phase 1 |
Recent Litigation for VIBATIV
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| THERAVANCE, INC. v. KAPPOS | 2009-11-04 |
Pharmacology for VIBATIV
| Drug Class | Lipoglycopeptide Antibacterial |
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 | |||
| 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0182971 | Start Trial |
| Hungary | 229370 | Start Trial |
| Australia | 6110701 | Start Trial |
| Austria | 388960 | Start Trial |
| Iceland | 2303 | Start Trial |
| Canada | 2408008 | Start Trial |
| >Country | >Patent Number | >Estimated 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 | 91908 | Luxembourg | Start Trial | 91908, EXPIRES: 20260501 |
| 1292612 | CA 2011 00033 | Denmark | Start Trial | PRODUCT NAME: TELAVANCIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER TELAVANCIN HYDROCHLORID |
| 1292612 | PA2012002,C1292612 | Lithuania | Start Trial | PRODUCT NAME: TELAVANCINUM; REGISTRATION NO/DATE: EU/1/11/705/001, 2011 09 02 EU/1/11/705/002 20110902 |
| 1292612 | 11C0051 | France | Start Trial | PRODUCT NAME: TELAVANCINE; REGISTRATION NO/DATE: 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 |
