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XACDURO (COPACKAGED) Drug Patent Profile

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Which patents cover Xacduro (copackaged), and what generic alternatives are available?

Xacduro (copackaged) is a drug marketed by Entasis Therap and is included in one NDA. There are four patents protecting this drug.

This drug has seventy-seven patent family members in forty-two countries.

The generic ingredient in XACDURO (COPACKAGED) is durlobactam sodium; durlobactam sodium; sulbactam sodium. One supplier is listed for this compound. Additional details are available on the durlobactam sodium; durlobactam sodium; sulbactam sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Xacduro (copackaged)

Xacduro (copackaged) will be eligible for patent challenges on May 23, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 23, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XACDURO (COPACKAGED)

International Patents:	77
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
DailyMed Link:	XACDURO (COPACKAGED) at DailyMed

Drug patent expirations by year for XACDURO (COPACKAGED)

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

Generic Entry Date for XACDURO (COPACKAGED)^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: GENERATING ANTIBIOTIC INCENTIVES NOW NDA: 216974 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.

Anatomical Therapeutic Chemical (ATC) Classes for XACDURO (COPACKAGED)

J01CG	Beta-lactamase inhibitors
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for XACDURO (COPACKAGED)

XACDURO (COPACKAGED) is protected by four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XACDURO (COPACKAGED) is ⤷ Sign Up.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.
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 XACDURO (COPACKAGED)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)

FDA Regulatory Exclusivity protecting XACDURO (COPACKAGED)

NEW CHEMICAL ENTITY
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
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for XACDURO (COPACKAGED)

When does loss-of-exclusivity occur for XACDURO (COPACKAGED)?

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

Argentina

Patent: 0539
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 13245399
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2014024279
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 66467
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 14002589
Estimated Expiration: ⤷ Sign Up

China

Patent: 4364254
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 71137
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 140428
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0180450
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 20269
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 34239
Estimated Expiration: ⤷ Sign Up

Dominican Republic

Patent: 014000212
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 34239
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 07071
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 36722
Estimated Expiration: ⤷ Sign Up

India

Patent: 82MUN2014
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 4660
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 22484
Estimated Expiration: ⤷ Sign Up

Patent: 15512440
Estimated Expiration: ⤷ Sign Up

Lithuania

Patent: 34239
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 6969
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 4627
Estimated Expiration: ⤷ Sign Up

Patent: 14011351
Estimated Expiration: ⤷ Sign Up

Montenegro

Patent: 031
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 383
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 0259
Estimated Expiration: ⤷ Sign Up

Norway

Patent: 35238
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 142403
Estimated Expiration: ⤷ Sign Up

Philippines

Patent: 014502224
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 34239
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 34239
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 45678
Estimated Expiration: ⤷ Sign Up

Patent: 14141579
Estimated Expiration: ⤷ Sign Up

Serbia

Patent: 966
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201405965R
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 34239
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2042867
Estimated Expiration: ⤷ Sign Up

Patent: 140140625
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 63416
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 97281
Estimated Expiration: ⤷ Sign Up

Patent: 1345907
Estimated Expiration: ⤷ Sign Up

Tunisia

Patent: 14000417
Estimated Expiration: ⤷ Sign Up

Uruguay

Patent: 723
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 XACDURO (COPACKAGED) around the world.

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Country	Patent Number	Title	Estimated Expiration
Portugal	3221313		⤷ Sign Up
Taiwan	201625234	Combination therapy for treatment of resistant bacterial infections	⤷ Sign Up
Eurasian Patent Organization	033829	КОМБИНИРОВАННАЯ ТЕРАПИЯ ДЛЯ ЛЕЧЕНИЯ УСТОЙЧИВЫХ БАКТЕРИАЛЬНЫХ ИНФЕКЦИЙ (COMBINATION THERAPY FOR TREATMENT OF RESISTANT BACTERIAL INFECTIONS)	⤷ Sign Up
Eurasian Patent Organization	201791069	КОМБИНИРОВАННАЯ ТЕРАПИЯ ДЛЯ ЛЕЧЕНИЯ УСТОЙЧИВЫХ БАКТЕРИАЛЬНЫХ ИНФЕКЦИЙ	⤷ Sign Up
Japan	2017533945	耐性細菌感染症の治療のための併用療法	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

Summary for XACDURO (COPACKAGED)

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XACDURO (COPACKAGED)

Anatomical Therapeutic Chemical (ATC) Classes for XACDURO (COPACKAGED)

Patents protecting XACDURO (COPACKAGED)

FDA Regulatory Exclusivity protecting XACDURO (COPACKAGED)

When does loss-of-exclusivity occur for XACDURO (COPACKAGED)?

Make Better Decisions: Try a trial or see plans & pricing

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