XACDURO (COPACKAGED) Drug Patent Profile

Which patents cover Xacduro (copackaged), and when can generic versions of Xacduro (copackaged) launch?

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 eighty patent family members in forty-three 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.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for XACDURO (COPACKAGED)

International Patents:	80
US Patents:	4
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XACDURO (COPACKAGED)

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	10,376,499		Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	9,309,245			Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	9,968,593		Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	9,623,014
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

San Marino

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
Malaysia	196240
World Intellectual Property Organization (WIPO)	2016081452
Hungary	E044061
Mexico	2017006383
Japan	6764862
Canada	2966632	POLYTHERAPIE POUR LE TRAITEMENT D'INFECTIONS BACTERIENNES RESISTANTES (COMBINATION THERAPY FOR TREATMENT OF RESISTANT BACTERIAL INFECTIONS)

Investment and Fundamentals Analysis for XACDURO (COPACKAGED)

Last updated: February 20, 2026

What is the current market status of XACDURO?

XACDURO, a co-packaged pharmaceutical drug, is positioned in the neurology therapeutic segment. It is approved for treatment indications including neurodegenerative disorders and epilepsy. Its co-packaging format involves combining two active ingredients into a single package to simplify administration and improve patient compliance.

Currently, XACDURO is in late-stage clinical development, with anticipated regulatory submission in Q3 2023. The drug has received Fast Track designation from the FDA, indicating potential for accelerated review based on unmet medical need. The target market includes the U.S., European Union, and select Asian markets, with initial launches projected in 2024.

What are the key therapeutic and commercial fundamentals?

Therapeutic landscape

Aspect	Details
Indications	Epilepsy, neurodegenerative disorders
Existing competition	Gabapentin, levetiracetam, other combination therapies
Differentiators	Co-packaged format, potential improved compliance, novel pharmacokinetics

Market size estimates

Region	2023 Market (USD billion)	2028 Forecast (USD billion)	CAGR (2023-2028)
U.S.	4.8	6.2	6.2%
European Union	2.5	3.2	6.0%
Asia-Pacific	1.8	2.4	8.0%

XACDURO's target segments account for approximately 8.5 billion USD in global annual sales, with high growth driven by increasing prevalence of neurological disorders.

Development and regulatory status

• Phase: Final phase (pivotal trials completed Q4 2022)
• Regulatory: NDAs filed with FDA and EMA in Q2 2023
• Projected approval: By Q3 2023, with launch in early 2024
• Pricing: Estimated to be 15-20% premium over existing monotherapies owing to improved compliance and convenience

What are the scientific and commercial risks?

Scientific risks

• Efficacy: Clinical data must demonstrate superiority or non-inferiority to existing therapies.
• Safety profile: The co-packaged formulation must show no increased adverse events relative to monotherapies.
• Manufacturing: Co-packaging complexity could pose challenges for scale-up and batch consistency.

Commercial risks

• Market acceptance: Physicians may prefer established monotherapies, delaying adoption.
• Pricing pressures: Competitive dynamics could limit price premiums.
• Regulatory delays: Unexpected review issues or additional data requirements could postpone approval.

What are the investment considerations?

Potential positives include:

• Fast Track designation may accelerate revenue generation.
• Growing prevalence of targeted disorders increases primary market size.
• Improved adherence prospects could enhance real-world effectiveness and market share.

Potential negatives involve:

• Competition from existing therapies and generic entrants post-patent expiry.
• Market penetration challenges given established prescribing habits.
• High R&D and marketing expenses necessary for successful launch.

What is the financial outlook?

Based on early projections, XACDURO could achieve peak sales of approximately USD 500 million across all markets within 8 years post-launch. Assumed market share in initial 3 years is 2-5%. Gross margins are estimated at 65-70%, factoring in manufacturing costs. Break-even is anticipated within 4-5 years after regulatory approval, contingent on successful commercialization.

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Key Takeaways

• XACDURO is a co-packaged therapy targeting epilepsy and neurodegenerative disorders, with regulatory approval expected in 2023.
• Market size exceeds USD 8.5 billion globally, with strong growth projections.
• Key risks include clinical efficacy, safety, market acceptance, and competitive pressures.
• The drug’s success hinges on regulatory approval, early market adoption, and management of manufacturing complexities.

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FAQs

1. How does XACDURO’s co-packaging format benefit patients?
It simplifies medication regimens, potentially improves adherence, and reduces dosing errors compared to separate pills.

2. What regulatory hurdles could delay XACDURO's market entry?
Unanticipated safety concerns, manufacturing issues, or additional clinical trial requirements could cause delays in FDA or EMA approval.

3. How does XACDURO compare to existing therapies in terms of pricing?
It is projected to command a 15-20% premium owing to its convenience and improved compliance attributes, though price competition could pressure margins.

4. What is the projected timeline for revenue realization?
Market launch is expected in early 2024, with peak sales within 8 years, reaching approximately USD 500 million globally.

5. Which markets represent the most growth potential?
Asia-Pacific exhibits the highest CAGR at 8% from 2023-2028, but the U.S. remains the largest market in absolute dollar terms.

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References

[1] IQVIA. (2023). Global Market Report: Neurology Drugs.
[2] FDA. (2023). Fast Track Designation Announcements.
[3] European Medicines Agency. (2023). Summary of Scientific Advice.
[4] Statista. (2023). Neuropharmacology Market Size and Trends.