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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. One supplier is listed for this compound. 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 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 5 |
| Clinical Trials: | 13 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
|---|---|
| Theravance Biopharma, US, Inc. | Phase 4 |
| Joseph Kuti | Phase 4 |
| Theravance Biopharma Antibiotics, Inc. | Phase 1 |
Pharmacology for VIBATIV
| Drug Class | Lipoglycopeptide Antibacterial |
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 |
International Patents for VIBATIV
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2713965 | Start Trial |
| Austria | 337334 | Start Trial |
| Austria | 337334 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIBATIV
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1292612 | CA 2011 00033 | Denmark | Start Trial | PRODUCT NAME: TELAVANCIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER TELAVANCIN HYDROCHLORID |
| 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 | 2011/037 | Ireland | Start Trial | PRODUCT NAME: TELAVANCIN, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TELAVANCIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/705/001-002 20110902 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
