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 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
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XACDURO (COPACKAGED)
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	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

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
Australia	2015350128
Brazil	112017010132
Canada	2966632

Xacduro (copackaged) market dynamics and financial trajectory: exclusivity, competitors, and revenue outlook

Last updated: May 29, 2026

Xacduro (copackaged) is a branded pharmaceutical marketed in the US as a two-ingredient regimen. The market’s near-term price and volume path is determined primarily by (1) how payers adjudicate the copackaged product vs. its components, (2) competitive uptake from single-agent and copackage alternatives, and (3) the regulatory and patent timeline that governs generic or biosimilar substitution risk.

The full market and financial trajectory cannot be completed from the information provided.

Market dynamics for Xacduro (copackaged): how payers, formularies, and contracting shape uptake?

Xacduro’s commercial performance is driven by payer policy on copackaged therapy versus purchasing the component drugs separately. Copackaging often changes:

• Patient access speed via step edits that differ from single-agent coverage
• Net price via rebates negotiated on a packaged unit rather than per-drug
• Persistence and switching behavior if the copackage is treated as a single line item

Key dynamic to track

• Rebate intensity tied to formulary placement and utilization thresholds.
• Mix shift between commercial and government formularies, which often differ in their handling of branded combos.

What is Xacduro (copackaged) compared to: component-by-component substitution risk?

The principal substitution risk is that payers and providers treat copackaged therapy as functionally equivalent to separate sourcing of the components once generic availability appears for either ingredient.

Competitive positioning questions that matter

• Are the components independently competitive (genericized) in the same time window?
• Do payers require prior authorization for either component separately, making the copackaged option administratively easier to obtain?
• Are clinicians locked into one regimen by guideline language or practice patterns that reference the packaged brand by name?

When does Xacduro lose exclusivity: patent expiration and regulatory exclusivity timeline

A complete exclusivity timeline requires the Orange Book listing(s) for the specific Xacduro NDA(s), including expiration of patent(s) and periods of market exclusivity (including exclusivity under the Hatch-Waxman framework or other statutory exclusivities). That timeline cannot be produced from the information provided.

What is the Orange Book status of Xacduro (copackaged)?

Orange Book status requires:

• Listing of patents for the relevant NDA
• Status codes (expiration, pending, expired)
• Any carve-outs or delisting events

This cannot be completed without the specific NDA number(s) and the Orange Book entries for Xacduro.

What generic entry risks exist for Xacduro (copackaged): Paragraph IV, settlement, and launch timing?

Generic risk for a copackaged product depends on whether an applicant can make a commercially viable generic equivalent that matches the labeled copackaged configuration and dosing schedule.

Generic entry variables

• Whether a generic filer can satisfy the copackage labeling and packaging requirements
• Whether Paragraph IV certifications target formulation, method-of-use, or combination-related claims
• Whether a settlement agreement constrains launch dates or includes “authorized generic” provisions

A factual assessment requires the court docket history and settlement terms, which are not provided.

What patent estate strength supports Xacduro (copackaged) revenue protection?

Patent strength for combination and copackaged products is usually concentrated in one or more of these categories:

• Formulation or co-packaged composition claims
• Method-of-use claims tied to the regimen
• Manufacturing or packaging process claims
• Combination-specific claims that distinguish the product from separate component dosing

A quantified assessment requires a specific patent inventory and claim scope mapping to generic design-arounds. That inventory is not available in the prompt.

What litigation affects Xacduro (copackaged): Hatch-Waxman cases and outcomes

Patent-litigation-driven revenue risk is determined by:

• Whether any Paragraph IV cases have been filed for the NDA(s)
• The claim-by-claim outcomes at district court and the status on appeal
• Any time-bar or launch-trigger outcomes from settlement

No litigation docket details are included, so the litigation effect cannot be stated.

How strong is Xacduro’s financial trajectory: revenue drivers and downside risks?

Xacduro’s financial trajectory typically reflects:

• Unit demand growth or decline driven by line-of-therapy adoption
• Price and rebate changes from payer negotiation cycles
• Mix impacts from commercial vs government utilization
• Competitive erosion if alternatives gain formulary positioning
• Patent and exclusivity milestones affecting insurer confidence and wholesaler buying behavior

A complete trajectory requires at minimum: US net sales history, quarterly trend, channel inventory signals, and guidance or sell-side consensus. None is included.

Key commercial indicators to model for Xacduro (copackaged)

Even without proprietary internal data, public-commercial KPIs that govern trajectory include:

• Net sales by quarter and by channel (if published by the marketer)
• Script volume trend and prescriptions per treated patient
• Average discount and rebate dynamics inferred from payer commentary and filings
• Gross-to-net bridge to identify whether price or volume is driving changes
• Inventory and wholesaler buying behavior around anticipated generic risk windows

No such metrics are supplied.

Geographic coverage and market segmentation: where Xacduro performs best

Geographic coverage affects revenue stability due to:

• Different patent term extensions and exclusivity frameworks
• Different payer bargaining leverage
• Different competitive landscapes in EU vs US vs other jurisdictions

A country-by-country view cannot be created without specified marketing authorization and product registration details for Xacduro.

Does Xacduro face biosimilar risk?

Biosimilar risk applies to biologics. The prompt does not establish whether Xacduro includes biologic components or small-molecule ingredients. Without formulation identity and regulatory classification, biosimilar risk cannot be addressed as a factual statement.

Xacduro vs. competing regimens: where market share erosion is most likely

The highest-likelihood erosion scenarios for copackaged products are:

• Competitors that can offer lower net cost at formulary tier placement
• Competitors with equivalent outcomes that reduce prior authorization friction
• Regimens that are preferred in clinical pathways or guidelines that reference the alternative by name

A comparison table requires identification of the nearest labeled competitors and their patent/exclusivity status. Not provided.

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Key Takeaways

• Xacduro’s market dynamics are governed by copackaged contracting and substitution behavior tied to the components’ competitive status.
• The exclusivity and generic-entry profile cannot be determined from the prompt because Orange Book listings, NDA identifiers, and patent expiration data are not provided.
• A quantified financial trajectory (revenue growth, margins, and erosion timing) cannot be completed without US sales history and competitive/patent milestone data for Xacduro.

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FAQs

1. How do copackaged drugs maintain net price against generics of component ingredients?
2. What payer rules most often restrict copackaged combination access versus single-agent alternatives?
3. How do Paragraph IV certifications typically target copackaged products: formulation, method-of-use, or packaging?
4. What indicators predict wholesaler buying ahead of Xacduro exclusivity expiration?
5. Which competitive regimens usually erode copackaged product share first in the US market?

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References

1. United States Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed 2026-05-29).