Details for New Drug Application (NDA): 206494

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NDA 206494 describes AVYCAZ, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the AVYCAZ profile page.

The generic ingredient in AVYCAZ is avibactam sodium; ceftazidime. One supplier is listed for this compound. Additional details are available on the avibactam sodium; ceftazidime profile page.

Summary for 206494

Tradename:	AVYCAZ
Applicant:	Abbvie
Ingredient:	avibactam sodium; ceftazidime
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206494

Generic Entry Date for 206494^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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: 206494

Mechanism of Action	beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 206494

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494	NDA	Allergan, Inc.	0456-2700	0456-2700-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-2700-10) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0456-2700-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 0.5GM BASE;2GM/VIAL
Approval Date:	Feb 25, 2015	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Feb 25, 2025
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	Feb 25, 2020
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Dec 20, 2025
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 206494

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.