DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022110
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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 022110
Tradename: | VIBATIV |
Applicant: | Cumberland Pharms |
Ingredient: | telavancin hydrochloride |
Patents: | 11 |
Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 022110
Generic Entry Date for 022110*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 022110
Suppliers and Packaging for NDA: 022110
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110 | NDA | Theravance Biopharma R&D, Inc. | 62847-001 | 62847-001-01 | 1 VIAL, SINGLE-USE in 1 CONTAINER (62847-001-01) > 50 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 250MG BASE/VIAL | ||||
Approval Date: | Sep 11, 2009 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Sep 11, 2023 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | METHOD FOR TREATING BACTERIAL INFECTION | ||||||||
Patent: | Start Trial | Patent Expiration: | Aug 24, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Jun 5, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? |
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