Details for New Drug Application (NDA): 022110

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NDA 022110 describes VIBATIV, which is a drug marketed by Cumberland and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VIBATIV profile page.

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
Ingredient:	telavancin hydrochloride
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022110

Generic Entry Date for 022110^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

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	Cumberland Pharmaceuticals Inc.	66220-315	66220-315-11	1 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-11) / 50 mL in 1 VIAL, SINGLE-DOSE
VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110	NDA	Cumberland Pharmaceuticals Inc.	66220-315	66220-315-22	12 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-22) / 50 mL in 1 VIAL, SINGLE-DOSE

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:	⤷ Sign Up	Patent Expiration:	Jan 1, 2027	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 750MG BASE/VIAL
Approval Date:	Sep 11, 2009	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jan 1, 2027	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 022110

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009	⤷ Sign Up	⤷ Sign Up
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009	⤷ Sign Up	⤷ Sign Up
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009	⤷ Sign Up	⤷ Sign Up
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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