AVYCAZ Drug Patent Profile

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When do Avycaz patents expire, and what generic alternatives are available?

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

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

Indicators of Generic Entry

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Summary for AVYCAZ

International Patents:	194
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

US Patents and Regulatory Information for AVYCAZ

AVYCAZ is protected by nine US patents and three FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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

Heterocyclic compounds as inhibitors of beta-lactamases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting AVYCAZ

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
>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: ⤷ Try a Trial

Australia

Patent: 12270051
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2013032415
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 80403
Estimated Expiration: ⤷ Try a Trial

China

Patent: 3649051
Estimated Expiration: ⤷ Try a Trial

Patent: 5294690
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 21005
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 96615
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 9815
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 23800
Estimated Expiration: ⤷ Try a Trial

Patent: 42462
Estimated Expiration: ⤷ Try a Trial

Patent: 14517027
Estimated Expiration: ⤷ Try a Trial

Patent: 17036307
Estimated Expiration: ⤷ Try a Trial

Malaysia

Patent: 5730
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 1020
Estimated Expiration: ⤷ Try a Trial

Patent: 13014114
Estimated Expiration: ⤷ Try a Trial

Russian Federation

Patent: 10091
Estimated Expiration: ⤷ Try a Trial

Patent: 69076
Estimated Expiration: ⤷ Try a Trial

Patent: 14101244
Estimated Expiration: ⤷ Try a Trial

Patent: 17102358
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 5289
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 2143660
Estimated Expiration: ⤷ Try a Trial

Patent: 140040748
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 60404
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 65706
Estimated Expiration: ⤷ Try a Trial

Patent: 1317238
Estimated Expiration: ⤷ Try a Trial

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
Malaysia	140638	NEW HETEROCYCLIC COMPOUNDS, WHICH ARE ACTIVE AS INHIBITORS OF BETA-LACTAMASES	⤷ Try a Trial
Brazil	0307267		⤷ Try a Trial
Serbia	50214	NOVA HETEROCIKLIČNA JEDINJENJA, NJIHOVO DOBIJANJE I NJIHOVA UPOTREBA KAO MEDIKAMENATA, A NAROČITO KAO ANTI-BAKTERIJSKIH AGENASA (NEW HETEROCYCLIC COMPOUNDS, THEIR PREPARATIONS AND THEIR USE AS MEDICAMENTS, IN PARTICULAR AS ANTI-BACTERIAL AGENTS)	⤷ Try a Trial
Norway	335195		⤷ Try a Trial
>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	629	Finland	⤷ Try a Trial
1480644	C20160041 00213	Estonia	⤷ Try a Trial	PRODUCT NAME: TSEFTASIDIIM/AVIBAKTAAM;REG NO/DATE: EU/1/16/1109 28.06.2016
1480644	16C1019	France	⤷ Try a Trial	PRODUCT NAME: ASSOCIATION OU MELANGE PHARMACEUTIQUE RENFERMANT EN TANT QU'INGREDIENTS ACTIFS:(1) LA CEFTAZIDIME OU UN DES SES SELS ET (2) L'AVIBACTAM OU UN DE SES SELS; REGISTRATION NO/DATE: EU/1/16/1109 20160628
1480644	SPC/GB17/004	United Kingdom	⤷ Try a Trial	PRODUCT NAME: COMBINATION OF CEFTAZIDIME, OR A SALT THEREOF, AND AVIBACTAM, OR A SALT THEREOF; REGISTERED: UK EU/1/16/1109/001 20160628
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description