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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022110

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NDA 022110 describes VIBATIV, which is a drug marketed by Theravance Biopharma and is included in one NDA. It is available from two suppliers. There are eleven patents protecting this drug. Additional details are available on the VIBATIV profile page.

The generic ingredient in VIBATIV is telavancin hydrochloride. Two suppliers are listed for this compound. Additional details are available on the telavancin hydrochloride profile page.
Summary for 022110
Tradename:VIBATIV
Applicant:Theravance Biopharma
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
Ingredient-typeLipoglycopeptides
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, Inc. 52118-001 52118-001-01 1 VIAL, SINGLE-USE in 1 CONTAINER (52118-001-01) > 50 mL in 1 VIAL, SINGLE-USE
VIBATIV telavancin hydrochloride POWDER;INTRAVENOUS 022110 NDA Theravance, Inc. 52118-002 52118-002-01 1 VIAL, SINGLE-USE in 1 CONTAINER (52118-002-01) > 17 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INTRAVENOUSStrengthEQ 250MG BASE/VIAL
Approval Date:Sep 11, 2009TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 11, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD FOR TREATING BACTERIAL INFECTION
Patent:➤ Try a Free TrialPatent Expiration:Aug 24, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jun 5, 2021Product Flag?YSubstance Flag?Delist Request?

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