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XACDURO (COPACKAGED) Drug Patent Profile

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-eight 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

Summary for XACDURO (COPACKAGED)

International Patents:	78
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	XACDURO (COPACKAGED) at DailyMed

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

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.

US Patents and Regulatory Information for XACDURO (COPACKAGED)

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

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.

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			Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes				Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes			Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

European Patent Office

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Uruguay

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.

Country	Patent Number	Title	Estimated Expiration
Spain	2717776
Mexico	2014011351	COMPUESTOS HETEROCICLICOS COMO INHIBIDORES DE BETA-LACTAMASAS. (HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS.)
Japan	6122484
Morocco	37383	Compose heterobicycliques comme inhibiteurs de la beta lactamase
Japan	6764862
European Patent Office	3221313	POLYTHÉRAPIE POUR LE TRAITEMENT D'INFECTIONS BACTÉRIENNES RÉSISTANTES (COMBINATION THERAPY FOR TREATMENT OF RESISTANT BACTERIAL INFECTIONS)
Norway	2935238

XACDURO (COPACKAGED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XACDURO (Co-packaged)

Introduction to XACDURO

XACDURO, a co-packaged antibiotic consisting of sulbactam and durlobactam, has marked a significant milestone in the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii-calcoaceticus complex. This drug has been approved by the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA), making it a crucial addition to the arsenal against antibiotic-resistant infections.

Market Need and Demand

The market for treatments targeting Acinetobacter infections is substantial due to the high prevalence and severity of these infections. In the U.S., it is estimated that there are over 40,000 cases of Acinetobacter infections annually, with approximately 40% being carbapenem-resistant[1].

Globally, the threat is equally pressing. In China, for instance, there are approximately 300,000 cases of Acinetobacter infections each year, with about 74% of these being carbapenem-resistant[5]. This high demand for effective treatments drives the market dynamics for XACDURO.

Regulatory Approvals and Expansion

XACDURO received FDA approval in May 2023 for the treatment of HABP and VABP caused by Acinetobacter baumannii-calcoaceticus complex[1][5].

In addition to the U.S. market, XACDURO has also been approved in China by the NMPA, further expanding its global footprint. This approval was based on the positive results from the Phase 3 ATTACK trial, which demonstrated the drug's efficacy and safety compared to colistin[5].

Clinical Efficacy

The clinical efficacy of XACDURO has been robustly demonstrated through the ATTACK trial. The trial showed that XACDURO significantly lowered all-cause mortality rates and improved clinical cure rates compared to colistin. Specifically, XACDURO reduced the 28-day all-cause mortality rate to 19% compared to 32.3% for colistin, and achieved a clinical cure rate of 62% versus 40% for colistin[3].

Safety Profile

XACDURO has exhibited a favorable safety profile in clinical studies. It was well tolerated and showed a lower incidence of nephrotoxicity compared to colistin. Fewer serious adverse events were observed, and there was lower treatment discontinuation due to adverse reactions[1].

Financial Performance and Projections

Innoviva, the company behind XACDURO, has reported strong financial results driven in part by the drug's approval and market entry.

• Net Product Sales: In the second quarter of 2024, Innoviva reported a 38% year-over-year increase in net product sales, reaching $21.7 million. XACDURO contributed $2.4 million to this figure, indicating a promising start in the market[2].
• License Revenue: The company received $14.5 million in license revenue, including an $8 million milestone payment for XACDURO's approval in China. This highlights the drug's potential for generating significant revenue through international approvals and partnerships[2].
• Royalties: Innoviva also saw an increase in royalties from GSK, reaching $67.2 million in the second quarter of 2024, up from $65.7 million in the same period the previous year[2].

Market Forecast

The market for Acinetobacter pneumonia therapeutics is projected to grow significantly. By 2031, the market is expected to reach $927.1 million, growing at a CAGR of 5.30% from 2024 to 2031. This growth is driven by the increasing prevalence of antibiotic-resistant infections and the limited treatment options available[4].

Competitive Landscape

XACDURO enters a market where treatment options for Acinetobacter infections are limited and often ineffective. Its approval and positive clinical data position it as a differentiated therapeutic option. The recognition of XACDURO in important treatment guidelines further enhances its competitive standing, potentially boosting future sales[2].

Global Reach and Partnerships

The approval of XACDURO in both the U.S. and China underscores its global potential. Partnerships, such as the one with Zai Lab, are crucial for expanding the drug's reach and ensuring its availability in regions with high unmet medical needs[5].

Challenges and Opportunities

Despite the promising financial and clinical trajectory, there are challenges to consider. The net loss reported by Innoviva in the second quarter of 2024, primarily due to unfavorable changes in investment fair values, highlights the need for careful financial management. However, the completion of a $100 million share repurchase program and the focus on enhancing shareholder value through capital allocation and operational excellence are positive indicators[2].

Key Takeaways

• Regulatory Approvals: XACDURO has received FDA and NMPA approvals, marking significant milestones in its market entry.
• Clinical Efficacy: The drug has demonstrated superior efficacy compared to colistin in treating HABP/VABP caused by Acinetobacter.
• Financial Performance: Strong net product sales and license revenue indicate a promising financial trajectory.
• Market Forecast: The market for Acinetobacter pneumonia therapeutics is expected to grow significantly by 2031.
• Global Reach: Approvals in the U.S. and China, along with partnerships, are expanding XACDURO's global footprint.

FAQs

What is XACDURO used for?

XACDURO is used for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii-calcoaceticus complex in patients 18 years of age and older[1].

What are the key clinical findings of XACDURO?

XACDURO has shown a significant reduction in all-cause mortality rates and improved clinical cure rates compared to colistin in clinical trials[3].

How has XACDURO performed financially?

XACDURO contributed to a 38% year-over-year increase in net product sales for Innoviva, with additional revenue from license agreements and milestone payments[2].

What is the market forecast for Acinetobacter pneumonia therapeutics?

The market is expected to reach $927.1 million by 2031, growing at a CAGR of 5.30% from 2024 to 2031[4].

What are the regulatory approvals for XACDURO?

XACDURO has been approved by the U.S. FDA and China’s NMPA for the treatment of HABP and VABP caused by Acinetobacter baumannii-calcoaceticus complex[1][5].

Sources

1. Biospace: XACDURO®, The First and Only Antibiotic Developed to Target Acinetobacter, Now Available to Treat Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) in Adults.
2. Stock Titan: Innoviva Reports Second Quarter 2024 Financial Results.
3. XACDURO.com: Efficacy | XACDURO® (sulbactam for injection; durlobactam for injection).
4. GlobeNewswire: Acinetobacter Pneumonia Therapeutics Market to Reach USD 927.1 Million to 2031.
5. Biospace: Zai Lab and Innoviva Specialty Therapeutics Announce NMPA Approval for XACDURO® for Hospital-Acquired and Ventilator-Associated Pneumonia Caused by Acinetobacter baumannii-calcoaceticus complex in China.