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 June 15, 2032. 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

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.

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			Y	Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes				Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes			Y	Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes				Y

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
European Patent Office	1480644	COMPOSES HETEROCYCLIQUES, ACTIFS COMME INHIBITEURS DE BETA-LACTAMASES (NOVEL HETEROCYCLIC COMPOUNDS WHICH ARE ACTIVE AS INHIBITORS OF BETA+LACTAMASES)
Lithuania	PA2016037
Russian Federation	2012118247	ПОЛИМОРФНЫЕ И ПСЕВДОПОЛИМОРФНЫЕ ФОРМЫ ФАРМАЦЕВТИЧЕСКОГО СОЕДИНЕНИЯ
Slovakia	287597

Supplementary Protection Certificates for EMBLAVEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	300847	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1307457	C 2016 055	Romania		PRODUCT NAME: AVIBACTAM SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1109; DATE OF NATIONAL AUTHORISATION: 20160624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1109; DATE OF FIRST AUTHORISATION IN EEA: 20160624
1480644	C01480644/01	Switzerland		PRODUCT NAME: AVIBACTAM + CEFTAZIDIM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66890 05.06.2019
1480644	PA2016037,C1480644	Lithuania		PRODUCT NAME: FARMACINIS MISINYS ARBA DERINYS, APIMANTIS KAIP VEIKLIUOSIUS INGREDIENTUS (1) CEFTAZIDIMA ARBA JO DRUSKA IR (2) AVIBAKTAMA ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624

EMBLAVEO™ and the Evolving Battle Against Antimicrobial Resistance: Market Dynamics and Financial Trajectory

The U.S. FDA’s 2025 approval of EMBLAVEO™ (aztreonam and avibactam) marks a pivotal advancement in combating antimicrobial resistance (AMR), a global health crisis projected to cause over 39 million deaths by 2050[1][6]. As the first monobactam/β-lactamase inhibitor combination antibiotic, EMBLAVEO addresses multidrug-resistant Gram-negative infections, filling a critical therapeutic gap. Supported by AbbVie’s robust financial infrastructure and strategic partnerships with Pfizer and public health entities, the drug is poised to navigate the challenging antibiotics market. This report examines EMBLAVEO’s regulatory journey, commercialization strategy, financial potential, and broader implications for global health and pharmaceutical innovation.

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Global Antimicrobial Resistance Crisis and EMBLAVEO’s Emergence

The Urgency of Novel Antibiotics

Antimicrobial resistance has escalated into a public health emergency, with Gram-negative bacteria like Escherichia coli and Klebsiella pneumoniae developing resistance to nearly all β-lactam antibiotics[1][4]. These pathogens often co-produce metallo-β-lactamases (MBLs) and serine β-lactamases, rendering traditional therapies ineffective[5][7]. EMBLAVEO’s dual mechanism—aztreonam’s activity against MBLs and avibactam’s inhibition of serine enzymes—restores efficacy against these "superbugs"[1][15]. With AMR-linked deaths already exceeding 1.14 million annually[1][6], EMBLAVEO’s approval arrives at a critical juncture.

Economic and Clinical Burdens of AMR

The financial viability of antibiotics remains precarious due to short treatment durations, low pricing, and high development costs[4]. A 2022 ASPE report highlighted that the average annual revenue for an antibiotic ($46 million) pales against oncology drugs ($1.04 billion over nine quarters)[4]. EMBLAVEO’s success hinges on its ability to command premium pricing for its niche indication, though broader market challenges persist. AbbVie’s collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and EU’s Innovative Medicines Initiative (IMI) mitigated R&D costs, exemplifying public-private partnerships essential for AMR innovation[5][7].

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Regulatory Milestones and Clinical Efficacy

Accelerated FDA Approval Pathway

EMBLAVEO received Qualified Infectious Disease Product (QIDP) and Fast Track designations in 2019, enabling priority review and five years of exclusivity[1][8]. The FDA’s 2025 approval for complicated intra-abdominal infections (cIAI) relied on limited clinical data and the Phase 3 REVISIT trial, which demonstrated non-inferiority to meropenem in cure rates[7][15]. While this accelerated pathway addresses urgent needs, post-marketing surveillance will be critical to confirm long-term safety[1][6].

European Commission’s Early Embrace

The European Commission approved EMBLAVEO in April 2024 under accelerated assessment, validating its role in treating hospital-acquired pneumonia and cIAI[5][7]. This staggered global rollout—Europe first, followed by the U.S.—reflects divergent regulatory landscapes and reimbursement frameworks. Pfizer, holding ex-U.S. commercialization rights, leverages its international infrastructure to optimize access[5][15].

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Market Access and Commercialization Strategy

Targeting High-Acuity Settings

EMBLAVEO’s initial use will likely concentrate in hospitals treating multidrug-resistant infections, where clinicians face limited alternatives. Its $1–2 billion peak sales projection[9] assumes penetration into 20–30% of the $10+ billion cIAI market[9]. However, reliance on metronidazole co-administration may complicate adoption, necessitating physician education campaigns[6][15].

Pricing and Reimbursement Dynamics

The U.S. launch in Q3 2025[6][8] coincides with CMS initiatives to incentivize novel antibiotics through bundled payments. EMBLAVEO’s wholesale acquisition cost (WAC) is expected to exceed $5,000 per course, justified by its lifesaving potential[9]. In Europe, health technology assessments (HTAs) will weigh cost against reduced hospital stays and mortality, with Germany and France likely offering favorable reimbursement[5][7].

Competitive Landscape

EMBLAVEO enters a sparse field of MBL-targeting therapies. Competitors like cefiderocol (Shionogi) and meropenem-vaborbactam (Melinta) address overlapping indications but lack EMBLAVEO’s β-lactamase inhibitor synergy[15]. AbbVie’s first-mover advantage could erode if pipeline candidates like Venatorx’s ceftobiprole gain traction, though patent protections and QIDP exclusivity provide a five-year buffer[1][9].

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Financial Projections and Revenue Potential

Peak Sales and Market Penetration

Analysts project EMBLAVEO to achieve $1.2 billion in annual sales by 2030, driven by U.S. hospital adoption and EU tenders[9][16]. AbbVie’s recent $3 billion credit facility[3] and 70.4% gross margin[2] provide ample liquidity to fund launch activities. A key variable is the drug’s expansion into ventilator-associated pneumonia (VAP) and urinary tract infections (UTI), currently under EMA review[7].

Impact on AbbVie’s Portfolio Diversification

EMBLAVEO aligns with AbbVie’s strategy to reduce reliance on Humira, whose sales fell 49% in 2024[11][14]. Immunology drugs Skyrizi ($3.78B Q4 2024 sales[11]) and Rinvoq ($1.83B[11]) remain growth engines, but infectious diseases offer higher margins in niche markets. EMBLAVEO’s success could bolster AbbVie’s 2025 adjusted EPS guidance of $12.12–$12.32[10][11], reinforcing investor confidence during its pipeline transition.

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Strategic Implications for AbbVie and the Pharmaceutical Industry

Redefining the Antibiotics Business Model

EMBLAVEO’s development—supported by $500M+ in U.S. federal funding[4]—highlights how public subsidies can offset pharma’s risk aversion to antibiotics. AbbVie’s partnership with Pfizer[5][15] and BARDA[7] exemplifies collaborative models essential for sustaining AMR innovation. However, the sector still requires policy reforms, such as pull incentives and reimbursement guarantees, to attract long-term investment[4][8].

Future Pipeline Opportunities

AbbVie’s recent acquisitions (Cerevel Therapeutics, Aliada[10]) signal a focus on neuroscience and oncology, but EMBLAVEO’s traction may reignite interest in infectious diseases. Next-generation combinations targeting carbapenem-resistant pathogens could leverage EMBLAVEO’s β-lactamase platform, creating a franchise opportunity[1][7].

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Conclusion

EMBLAVEO emerges as a beacon of progress in the AMR crisis, combining scientific innovation with strategic commercialization. While its financial success is not assured in a challenging market, AbbLAVEO’s unique mechanism, regulatory incentives, and AbbVie’s execution capabilities position it to save lives and reshape antibiotic development paradigms. For the pharmaceutical industry, EMBLAVEO underscores the viability of partnerships and policy support in addressing global health threats. As AMR continues to escalate, EMBLAVEO’s journey will serve as a critical case study in balancing public health imperatives with commercial sustainability.

References

1. https://www.prnewswire.com/news-releases/us-fda-approves-emblaveo-aztreonam-and-avibactam-for-the-treatment-of-adults-with-complicated-intra-abdominal-infections-with-limited-or-no-treatment-options-302371478.html
2. https://uk.investing.com/news/company-news/fda-approves-novel-antibiotic-emblaveo-for-ciai-93CH-3914382
3. https://www.investing.com/news/company-news/fda-approves-novel-antibiotic-emblaveo-for-ciai-93CH-3857291
4. https://aspe.hhs.gov/sites/default/files/documents/b0962d8b3a6a3a825216485a4a988c76/antimicrobial-drugs-market-returns-analysis.pdf
5. https://www.pfizer.com/news/press-release/press-release-detail/european-commission-approves-pfizers-emblaveor-patients
6. https://medtigo.com/news/fda-approves-emblaveo-a-game-changer-for-intra-abdominal-infections/
7. https://www.europeanpharmaceuticalreview.com/news/227071/european-commission-approves-novel-antibiotic/
8. https://www.biospace.com/fda/abbvie-gets-fda-approval-for-new-antibiotic-in-the-face-of-rising-resistance
9. https://www.stocktitan.net/news/ABBV/u-s-fda-approves-emblaveotm-aztreonam-and-avibactam-for-the-o1w6k49ury6f.html
10. https://www.monexa.ai/blog/abbvie-navigating-market-shifts-and-pipeline-expan-ABBV-2025-02-26
11. https://www.marketscreener.com/quote/stock/ABBVIE-INC-12136589/news/AbbVie-4Q-Revenue-Tops-Estimates-as-Skyrizi-Rinvoq-Growth-Surges-48926654/
12. https://healtheconomics.com/abbotts-q1-2024-earnings-strong-medical-device-sales-lead-to-raised-financial-forecasts/
13. https://investors.abbvie.com/news-releases/news-release-details/abbvie-reports-full-year-and-fourth-quarter-2024-financial
14. https://ca.marketscreener.com/quote/stock/ABBVIE-INC-12136589/news/AbbVie-lifts-annual-profit-forecast-on-strong-immunology-drug-sales-47468559/
15. https://www.biopharmadive.com/news/abbvie-emblaveo-fda-approval-antibiotic-gram-negative/739675/
16. https://pandaforecast.com/stock_forecasts/forecast_abbv/