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AVYCAZ Drug Patent Profile

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When do Avycaz patents expire, and when can generic versions of Avycaz launch?

Avycaz is a drug marketed by Allergan and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-five patent family members in fifty-five countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Avycaz

Avycaz was eligible for patent challenges on February 25, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 15, 2032. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for AVYCAZ

International Patents:	195
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AVYCAZ
What excipients (inactive ingredients) are in AVYCAZ?	AVYCAZ excipients list
DailyMed Link:	AVYCAZ at DailyMed

Drug patent expirations by year for AVYCAZ

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

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

Recent Clinical Trials for AVYCAZ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1
Michigan State University	Phase 1
University of Southern California	Phase 4

See all AVYCAZ clinical trials

Pharmacology for AVYCAZ

Drug Class	Cephalosporin Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AVYCAZ

J01DD	Third-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for AVYCAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVYCAZ	For Injection	avibactam sodium; ceftazidime	0.5 g/2 g per vial	206494	2	2024-02-26

US Patents and Regulatory Information for AVYCAZ

AVYCAZ is protected by ten US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AVYCAZ is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting AVYCAZ

Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING BACTERIAL INFECTIONS IN COMPLICATED INTRA-ABDOMINAL INFECTION AND COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS, PATIENTS COMPRISING ADMINISTERING A BACTERICIDALLY EFFECTIVE AMOUNT OF AVIBACTAM SODIUM

Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING BACTERIAL INFECTIONS IN HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) PATIENTS COMPRISING ADMINISTERING A BACTERICIDALLY EFFECTIVE AMOUNT OF AVIBACTAM SODIUM

Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS, COMPLICATED URINARY TRACT INFECTIONS, AND HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA IN ADULT AND PEDIATRIC PATIENTS (AT LEAST 31 WEEKS GESTATIONAL AGE)

Heterocyclic compounds as inhibitors of beta-lactamases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting AVYCAZ

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for AVYCAZ

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	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

International Patents for AVYCAZ

When does loss-of-exclusivity occur for AVYCAZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 6972
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 12270051
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2013032415
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 80403
Estimated Expiration: ⤷ Sign Up

China

Patent: 3649051
Estimated Expiration: ⤷ Sign Up

Patent: 5294690
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 21005
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 96615
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 9815
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 23800
Estimated Expiration: ⤷ Sign Up

Patent: 42462
Estimated Expiration: ⤷ Sign Up

Patent: 14517027
Estimated Expiration: ⤷ Sign Up

Patent: 17036307
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 5730
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 1020
Estimated Expiration: ⤷ Sign Up

Patent: 13014114
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 10091
Estimated Expiration: ⤷ Sign Up

Patent: 69076
Estimated Expiration: ⤷ Sign Up

Patent: 14101244
Estimated Expiration: ⤷ Sign Up

Patent: 17102358
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 5289
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2143660
Estimated Expiration: ⤷ Sign Up

Patent: 140040748
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 60404
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 65706
Estimated Expiration: ⤷ Sign Up

Patent: 1317238
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AVYCAZ around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20040081473		⤷ Sign Up
Canada	2780403	PROCEDES DE PREPARATION DE COMPOSES HETEROCYCLIQUES, Y COMPRIS LE TRANS-7-OXO-6-(SULFOXY)-1,6-DIAZABICYCLO¬3,2,1\|OCTANE-2-CARBOXAMIDE ET SES SELS (PROCESSES FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF)	⤷ Sign Up
Japan	6197170		⤷ Sign Up
France	2951171	NOUVEAU SEL DE SODIUM D'UN COMPOSE AZABICYCLIQUE SOUS FORME ENANTIOMERE CRISTALLISEE ET NOUVELLES FORMES POLYMORPHES ET PSEUDOPOLYMORPHES AINSI QUE LEUR PREPARATION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AVYCAZ

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	93338	Luxembourg	⤷ Sign Up	PRODUCT NAME: MELANGE OU ASSOCIATION PHARMACEUTIQUE COMPRENANT COMME INGREDIENTS ACTIFS : (1) CEFTAZIDIME OU UN SEL DE CELUI-CI ET (2) AVIBACTAM OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1109 - ZAVICEFTA - CEFTAZIDIME/AVIBACTAM
1480644	CA 2016 00059	Denmark	⤷ Sign Up	PRODUCT NAME: FARMACEUTISK BLANDING ELLER SAMMENSAETNING DER SOM AKTIVE BESTANDDELE DERAF, HERUNDER CEFTAZIDIMPENTAHYDRAT OG AVIBACTAMNATRIUM; REG. NO/DATE: EU/1/16/1109 20160628
1480644	300847	Netherlands	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1480644	PA2016037,C1480644	Lithuania	⤷ Sign Up	PRODUCT NAME: FARMACINIS MISINYS ARBA DERINYS, APIMANTIS KAIP VEIKLIUOSIUS INGREDIENTUS (1) CEFTAZIDIMA ARBA JO DRUSKA IR (2) AVIBAKTAMA ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description