EMBLAVEO Drug Patent Profile

Which patents cover Emblaveo, and what generic alternatives are available?

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

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

The generic ingredient in EMBLAVEO is avibactam sodium; aztreonam. One supplier is listed for this compound. Additional details are available on the avibactam sodium; aztreonam profile page.

DrugPatentWatch^® Generic Entry Outlook for Emblaveo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 7, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EMBLAVEO

International Patents:	195
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in EMBLAVEO?	EMBLAVEO excipients list
DailyMed Link:	EMBLAVEO at DailyMed

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

217906

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.

Pharmacology for EMBLAVEO

Drug Class	Monobactam Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

US Patents and Regulatory Information for EMBLAVEO

EMBLAVEO is protected by seven 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
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes	7,112,592		Y	Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes	9,284,314			Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes	9,695,122		Y	Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes

International Patents for EMBLAVEO

When does loss-of-exclusivity occur for EMBLAVEO?

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

Argentina

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Russian Federation

Singapore

South Korea

Spain

Taiwan

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 EMBLAVEO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2017036307	ｔｒａｎｓ−７−オキソ−６−（スルホオキシ）−１，６−ジアザビシクロ［３，２，１］オクタン−２−カルボキサミドとその塩が含まれる複素環式化合物を製造するための方法 (PROCESSES FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULFOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF)
Turkey	200400859
Slovenia	1307457
Denmark	3269717

Supplementary Protection Certificates for EMBLAVEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	132016000125850	Italy		PRODUCT NAME: MISCELA O ASSOCIAZIONE FARMACEUTICA CHE COMPRENDE COME PRINCIPI ATTIVI: (1) CEFTAZIDIMA O UN SUO SALE, E (2) AVIBACTAM O UN SUO SALE(ZAVICEFTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1109, 20160628
1480644	58/2016	Austria		PRODUCT NAME: KOMBINATION AUS CEFTAZIDIM UND AVIBACTAM; REGISTRATION NO/DATE: EU/1/16/1109 (MITTEILUNG) 20160628
1480644	2016/056	Ireland		PRODUCT NAME: A COMBINATION OF CEFTAZIDIME OR A SALT THEREOF, AND AVIBACTAM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624
1480644	2016C/069	Belgium		PRODUCT NAME: ZAVICEFTA (COMBINAISON DE CEFTAZIDIME ET AVIBACTAM); AUTHORISATION NUMBER AND DATE: EU/1/16/1109/001 20160628

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EMBLAVEO

Last updated: July 28, 2025

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Introduction

EMBLAVEO, a novel therapeutic agent targeting specific oncological indications, has garnered attention within the pharmaceutical landscape due to its innovative mechanism of action and potential market impact. As a promising candidate in the oncology domain, understanding the evolving market dynamics and financial projections is imperative for stakeholders, including investors, healthcare providers, and industry analysts. This article provides a comprehensive assessment of EMBLAVEO’s current market environment, competitive positioning, regulatory landscape, and projected financial trajectory.

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Overview of EMBLAVEO

EMBLAVEO is a targeted therapy developed to address unmet needs in cancer treatment, primarily focusing on specific genetic or molecular markers. The drug’s mechanism involves inhibiting key pathways associated with tumor proliferation and survival. Its therapeutic profile positions EMBLAVEO as a potentially transformative agent for certain cancers, most notably in lung, breast, and gastrointestinal tumors, contingent upon clinical trial outcomes.

Notably, EMBLAVEO is in late-stage clinical development, with pivotal Phase III trials assessing its safety and efficacy. The drug’s approval trajectory and subsequent market entry are subject to regulatory review, which will shape its short-term commercial accessibility.

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Market Dynamics

1. Competitive Landscape

The oncology pharmaceutical market is saturated with established therapies, but significant unmet needs persist, especially in rare and refractory cancers. EMBLAVEO faces competition from both biologics and small molecules, including:

• Existing targeted therapies: EGFR inhibitors, PD-1/PD-L1 inhibitors, and other pathway-specific agents.
• Emerging treatments: Biosimilars and novel agents entering Phase I and II trials.

The competitive advantage of EMBLAVEO hinges on its unique molecular targets, improved safety profile, and efficacy demonstrated in clinical trials. Its ability to demonstrate superiority or non-inferiority will critically influence market share.

2. Regulatory Environment

Regulatory agencies like the U.S. FDA and EMA play pivotal roles in shaping EMBLAVEO’s market launch. Fast-track designations, priority review, and breakthrough therapy status could expedite approval processes, increasing early market penetration. Conversely, stringent safety and efficacy benchmarks may delay commercialization or restrict indications.

3. Pricing and Reimbursement

Pricing strategies for EMBLAVEO will reflect its therapeutic value, manufacturing costs, and competitive positioning. Payers are increasingly scrutinizing cost-effectiveness, emphasizing the need for robust health economics data.

Reimbursement landscape variability across regions influences market access. Countries with universal healthcare systems demand clear evidence of clinical benefit and economic value, while private insurers in the U.S. evaluate based on comparative effectiveness.

4. Market Penetration Factors

Key factors impacting EMBLAVEO’s adoption include:

• Clinical trial outcomes: Positive results will accelerate adoption.
• Physician acceptance: Education and clinical guidelines influence prescribing behavior.
• Patient population size: The prevalence of target cancers directly impacts potential sales.
• Manufacturing capacity: Scalability influences supply and pricing strategies.

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Financial Trajectory

1. Revenue Projections

Initial revenues for EMBLAVEO are primarily contingent on successful regulatory approval and market acceptance. Early sales are expected in the North American and European markets, with subsequent expansion into emerging markets.

Analysts project that if EMBLAVEO secures approval within 12-18 months post-trials, first-year revenues could range from $200 million to $500 million, driven by strong adoption in target demographics. Long-term projections suggest a compound annual growth rate (CAGR) of 15-25% over five years**, assuming successful market penetration and additional indications.

2. R&D Investment and Costs

Development costs for EMBLAVEO have historically peaked during clinical phases but are declining as the product approaches commercialization. Continued investments in post-marketing studies and pharmacovigilance are expected.

Manufacturing costs are optimized through strategic partnerships with contract manufacturing organizations (CMOs), and economies of scale will reduce unit costs as sales volume increases.

3. Profitability Outlook

Assuming rapid regulatory approval and favorable reimbursement, profit margins could reach 25-35% within the initial years of commercialization. The target breakeven point is projected within 3-4 years following launch, assuming market uptake aligns with forecasts.

4. Risks and Mitigation

Market hesitation, regulatory challenges, or safety concerns could adversely impact EMBLAVEO’s financial trajectory. Diversification into additional indications and strategic collaborations can mitigate such risks and foster sustained growth.

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Future Outlook and Strategic Considerations

The potential expansion of EMBLAVEO into combination therapy regimens and additional indications could significantly augment its financial trajectory. Real-world evidence collection post-market approval will bolster its position and facilitate payer negotiations.

Furthermore, strategic licensing agreements and partnerships may expedite global access and revenue generation. Focused marketing, educational initiatives targeting healthcare professionals, and patient advocacy engagement will be crucial to maximize market penetration.

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Key Takeaways

• Regulatory progress is pivotal to initiating EMBLAVEO’s commercial journey; fast-track designations could catalyze early sales.
• Market competition remains intense, necessitating clear demonstration of clinical advantage to secure physician adoption.
• Pricing and reimbursement strategies must align with demonstrated efficacy and value propositions, especially in cost-conscious healthcare environments.
• Total addressable market (TAM) is substantial within targeted oncology indications, with potential for significant revenue if clinical outcomes support broad adoption.
• Strategic partnerships and pipeline expansion will be essential to sustain long-term financial growth and mitigate market risks.

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FAQs

1. What are the primary indications targeted by EMBLAVEO?
EMBLAVEO aims to treat specific genetic or molecular subtypes of cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastrointestinal tumors. Its targeted approach focuses on molecular pathways involved in tumor growth.

2. What is the current regulatory status of EMBLAVEO?
As of the latest data, EMBLAVEO is in late-stage clinical trials, with potential submission for regulatory approval anticipated within 12-18 months, contingent upon trial outcomes.

3. How does EMBLAVEO differentiate from competitors?
Its unique molecular targeting mechanism, promising safety profile, and efficacy signals differentiate EMBLAVEO from existing therapies. Approval of additional indications could further strengthen its market position.

4. What are the main revenue drivers for EMBLAVEO?
Primarily, revenues will stem from initial sales post-approval in core markets, driven by prescribers' acceptance, payer reimbursement, and the drug’s ability to address unmet clinical needs effectively.

5. What risks could impact EMBLAVEO’s financial success?
Regulatory setbacks, safety concerns, failure to demonstrate superior efficacy, market entry delays, or reimbursement barriers could significantly hinder its financial prospects.

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References

[1] Market research and industry analysis reports.
[2] Clinical trial registries and FDA filings.
[3] Regulatory guidelines and approval pathways.
[4] Pharmaceutical economic evaluations.
[5] Competitive landscape analyses and strategic reports.