Cefepime hydrochloride; enmetazobactam - Generic Drug Details

What are the generic drug sources for cefepime hydrochloride; enmetazobactam and what is the scope of patent protection?

Cefepime hydrochloride; enmetazobactam is the generic ingredient in one branded drug marketed by Orchid Pharma and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cefepime hydrochloride; enmetazobactam has twenty-five patent family members in eighteen countries.

Summary for cefepime hydrochloride; enmetazobactam

International Patents:	25
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	cefepime hydrochloride; enmetazobactam at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cefepime hydrochloride; enmetazobactam

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

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.

Recent Clinical Trials for cefepime hydrochloride; enmetazobactam

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Allecra	Phase 2
Linical Co., Ltd.	Phase 2

See all cefepime hydrochloride; enmetazobactam clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for cefepime hydrochloride; enmetazobactam

J01DE	Fourth-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for cefepime hydrochloride; enmetazobactam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orchid Pharma	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No	7,687,488		Y	Y
Orchid Pharma	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No
Orchid Pharma	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No	11,124,526
Orchid Pharma	EXBLIFEP	cefepime hydrochloride; enmetazobactam	POWDER;INTRAVENOUS	216165-001	Feb 22, 2024		DISCN	Yes	No

International Patents for cefepime hydrochloride; enmetazobactam

Country	Patent Number	Title	Estimated Expiration
Cyprus	1114927
South Korea	20160081964	결정성 베타-락타마아제 억제제 (CRYSTALLINE BETA-LACTAMASE INHIBITOR)
Eurasian Patent Organization	031348	КРИСТАЛЛИЧЕСКИЙ ИНГИБИТОР β-ЛАКТАМАЗЫ (CRYSTALLINE BETA-LACTAMASE INHIBITOR)
Australia	2014345507	Crystalline beta-lactamase inhibitor

Market Dynamics and Financial Trajectory for Cefepime Hydrochloride and Enmetazobactam

Last updated: February 17, 2026

Overview of the Drugs

Cefepime hydrochloride is a fourth-generation cephalosporin antibiotic approved for treating serious bacterial infections, including pneumonia, urinary tract infections, and skin infections. It is marketed globally, with broad-spectrum activity against gram-positive and gram-negative bacteria.

Enmetazobactam is a beta-lactamase inhibitor under development to restore the efficacy of beta-lactam antibiotics against resistant bacterial strains. It is primarily combined with other antibiotics, such as cefepime, to combat multidrug-resistant infections.

Market Size and Growth Drivers

Global Antibiotics Market: Estimated to reach $52.3 billion in 2023, with a compound annual growth rate (CAGR) of 3.7% projected through 2030. The rise in antibiotic resistance, aging populations, and increasing infection rates drive this growth.

Market for Cefepime: The global cefepime market is expected to expand at a CAGR of 4% over the next five years. Key applications include hospital-acquired pneumonia and complicated urinary tract infections.

Market for Enmetazobactam Combinations: The beta-lactamase inhibitor segment is anticipated to grow faster, with an CAGR above 8%, driven by unmet needs in resistant bacterial infections.

Key Market Players and Pipeline Status

• Pfizer markets cefepime; it holds a dominant position with ongoing formulations and patent protections.

• Navamed Pharmaceuticals is developing enmetazobactam, with clinical trials assessing its efficacy in combination therapies.

• Several competitors, such as Entasis Therapeutics and Nuventra, are in early development stages for similar beta-lactamase inhibitors.

Financial Trajectory

Revenue Projections: Pfizer's cefepime portfolio generates approximately $700 million worldwide annually (2022). Considering patent expiration risks and generic displacement, revenue could decline by 2-3% annually post-2025 unless new formulations or combinations are introduced.

Enmetazobactam's Development Costs and Potential: Enmetazobactam may require an average investment of $250 million over clinical phases. If successful, combined therapy approvals could lead to peak sales of $1 billion annually within 7-10 years, driven by antibiotic resistance trends.

Pricing Dynamics: The unit price for cefepime varies globally, from approximately $50 per vial in the US to lower prices in emerging markets. Enmetazobactam combination therapies could command a premium of 20-30%, particularly for resistant infections.

Regulatory and Patent Outlook

• Pfizer's cefepime claims patent protection until 2025 in key markets; generics may enter thereafter.

• Enmetazobactam is in late-stage clinical trials as of 2023, with potential FDA approval by 2026. Patent exclusivity could extend 10-12 years post-approval, depending on filings.

Market Challenges and Risks

• Increasing antibiotic resistance could reduce cefepime’s effectiveness, prompting market share declines unless new combinations like enmetazobactam are adopted.

• Regulatory delays or failures in clinical trials for enmetazobactam could hinder its commercial viability.

• Pricing pressures, particularly in government-funded healthcare systems, could limit profit margins.

Emerging Trends

• Growing interest in antibiotic stewardship programs reduces overuse, impacting sales volume.

• Personalized medicine approaches demand tailored antibiotic regimens, influencing drug development.

• Global health initiatives prioritize combating resistant infections, boosting demand for beta-lactamase inhibitors.

Concluding Remarks on Financial Outlook

Cefepime hydrochloride remains a core antibiotic, with stable but plateauing revenues. The emergence of enmetazobactam offers potential upside if clinical and regulatory hurdles are crossed. Market growth hinges on addressing antibiotic resistance and maintaining appropriate pricing strategies.

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Key Takeaways

• Cefepime's market size is approximately $700 million annually, facing moderate growth and patent expiration risks.

• Enmetazobactam's development aims to address antibiotic resistance, with potential peak sales of $1 billion post-approval.

• Market expansion is driven by increasing resistance, but regulatory, pricing, and competition risks persist.

• Future revenues depend heavily on successful clinical development, regulatory approval, and adoption in resistant infection treatment protocols.

• Antibiotic stewardship and health policy shifts influence sales dynamics and market potential.

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FAQs

1. What is the primary driver for cefepime's market growth?

   Increasing bacterial resistance and hospital-acquired infections sustain demand for broad-spectrum antibiotics like cefepime.

2. How does enmetazobactam aim to impact the antibiotic market?

   By restoring efficacy against resistant bacteria through beta-lactamase inhibition, it offers a solution to rising resistance, potentially capturing significant market share.

3. What are the main risks associated with enmetazobactam's market success?

   Clinical trial failures, regulatory delays, and competition from other inhibitors or antibiotics pose significant risks.

4. When is enmetazobactam expected to reach the market?

   Late-stage clinical trials are underway, with FDA approval targeted for 2026, subject to trial outcomes.

5. How might patent expirations affect the cefepime market?

   Patent expirations around 2025 could lead to generic entry, reducing revenues unless new formulations or combinations are developed.

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Sources

[1] MarketsandMarkets. "Global Antibiotics Market," 2023.

[2] Pfizer Annual Report 2022.

[3] ClinicalTrials.gov. "Enmetazobactam clinical trials," 2023.

[4] IQVIA. "Pharmaceutical Market Data," 2022.

[5] OECD Health Data. "Global Health and Drug Resistance Trends," 2023.