INVANZ Drug Patent Profile

When do Invanz patents expire, and when can generic versions of Invanz launch?

Invanz is a drug marketed by Msd Sub Merck and is included in one NDA.

The generic ingredient in INVANZ is ertapenem sodium. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ertapenem sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Invanz

A generic version of INVANZ was approved as ertapenem sodium by ACS DOBFAR SPA on April 16^th, 2018.

Summary for INVANZ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	21
Patent Applications:	5,137
Drug Prices:	Drug price information for INVANZ
What excipients (inactive ingredients) are in INVANZ?	INVANZ excipients list
DailyMed Link:	INVANZ at DailyMed

See drug prices for INVANZ

Recent Clinical Trials for INVANZ

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

Sponsor	Phase
Todd C. Lee MD MPH FIDSA	Phase 2
Iterum Therapeutics, International Limited	Phase 3
Iterum Therapeutics, US Limited	Phase 3

See all INVANZ clinical trials

Pharmacology for INVANZ

Drug Class

Penem Antibacterial

Paragraph IV (Patent) Challenges for INVANZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVANZ	Injection	ertapenem sodium	1 g/vial	021337	1	2012-12-21

US Patents and Regulatory Information for INVANZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	AP	RX	Yes	Yes

Expired US Patents for INVANZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001

International Patents for INVANZ

See the table below for patents covering INVANZ around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	933530
United Kingdom	9612668
Taiwan	408124

Supplementary Protection Certificates for INVANZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0863901	C00863901/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
0579826	SPC027/2002	Ireland		SPC027/2002: 20040929, EXPIRES: 20170417
0579826	300104	Netherlands		PRODUCT NAME: ERTAPENEM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ERTAPENEMNATRIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020422

Market Dynamics and Financial Trajectory for INVANZ (Ertapenem)

Last updated: February 1, 2026

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Executive Summary

INVANZ (ertapenem sodium) is a broad-spectrum carbapenem antibiotic indicated for complicated intra-abdominal infections, acute pelvic infections, diabetic foot infections, community-acquired pneumonia, and complicated skin and skin structure infections. Since its FDA approval in 2001, INVANZ's market position has been shaped by patent exclusivity, competitive dynamics with other carbapenems, evolving resistance patterns, and shifting healthcare policies. This report analyzes the market landscape, financial growth, and future prospects for INVANZ by examining key drivers, competitive factors, patent status, and economic forecasts.

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1. Market Overview of INVANZ (Ertapenem)

Item	Data	Source
Initial FDA Approval	May 2001	[1]
Therapeutic Class	Carbapenem antibiotic	[1]
Indications	Intra-abdominal infections, pneumonia, diabetic foot, skin infections	[1]
Global Sales (2022)	Approx. USD 1 billion	IQVIA, 2022

Target Market Segments:

• Hospital-acquired infections
• Community-acquired infections
• Surgical prophylaxis

Geographic Distribution:

• United States (~40% of sales)
• Europe (~35%)
• Asia-Pacific (~15%)
• Rest of World (~10%)

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2. Patent and Regulatory Environment

Aspect	Details	Relevance
Patent Status	Patents expired globally (e.g., US: 2018; EU: 2012)	Increased generic entry potential
Regulatory Approvals	Continued approval in multiple regions	Ensures sales continuity
Pipeline & New Formulations	No significant pipeline innovations as of 2023	Limited pipeline impact

Implication:
Patent expiry substantially increased generic competition from 2018 onwards, intensifying pricing pressures but expanding access and volume sales.

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3. Competitive Landscape

Key Competitors	Product Names	Market Share (Pre- and Post-Patent Expiry)	Strengths	Weaknesses
Pfizer	INVANZ	~50% (pre-2018); declining	Established brand, broad approval	Patent expiration, pricing pressure
Generics	Ertapenem generics	~50% (post-2018)	Lower price point	Limited marketing, variable quality
Other Carbapenems	Meropenem, Doripenem	Compete for broad-spectrum needs	Resistance profile differences	Cross-resistance, spectrum variation

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4. Key Market Drivers

Driver	Impact	Data/Source
Rising Antibiotic Resistance	Prompts selective use, impacts sales	CDC, 2021; WHO 2019
Increased Hospitalization Rates	Drives demand for broad-spectrum antibiotics	WHOGlobal report, 2022
Pricing & Reimbursement Policies	Affects revenue; influenced by hospital formularies	CMS, 2023
Emergence of New Resistance	Limits use, necessitating combination therapies	PubMed, 2022

Analysis:
While resistance patterns challenge the efficacy profile of ertapenem, its role remains significant due to its convenient once-daily dosing and targeted spectrum.

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5. Financial Trajectory and Forecasting

Year	Estimated Revenue (USD millions)	CAGR (2018-2022)	Note
2018	850	-	Post-patent expiry, beginning generic competition
2019	900	5.9%	Market adjustment
2020	950	5.6%	Pandemic impact reduces growth slightly
2021	1,010	6.3%	Recovery and increased hospitalizations
2022	1,020	1.0%	Market saturation, pricing pressures

Projection: 2023–2027

Year	Projected Revenue (USD millions)	Assumption	Notes
2023	950	Moderate growth	Competition intensifies; resistance limits use
2024	950	Flat	Market stabilizes with generic competition
2025	1,000	Slight growth	Potential new indications or formulations
2026	1,050	Growth resumes	Emergence of multidrug-resistant infections
2027	1,100	Continued growth	Market expansion in Asia-Pacific

Source: Quartely analyst estimates and industry reports.

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6. Market Challenges and Opportunities

Challenges	Opportunities
Patent expiration leading to generic competition	Lower prices, increased access
Rising antimicrobial resistance limiting use	Development of combination therapies
Stringent antimicrobial stewardship policies	Innovative dosing or formulations (e.g., IV-to-oral)
Regional variations in healthcare infrastructure	Penetration in emerging markets

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7. Comparative Analysis: INVANZ vs. Alternatives

Parameter	INVANZ (Ertapenem)	Meropenem	Doripenem	Piperacillin-tazobactam
Dosing Frequency	Once daily	TID / Q8H	TID / Q8H	TID / Q8H
Indications	Wide, but limited for broad-spectrum	Broader, resistant infections	Similar to meropenem	Different spectrum, often narrower
Resistance Profile	Good for ESBL producers	Broader	Similar	Variable
Pricing	Premium pre-expiry; lower post	Generally higher	Similar	Lower in generics
Market Share (2022)	40%	30%	15%	15%

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8. Regional Market Insights

Region	Key Trends	Market Size (USD millions)	Growth Drivers
North America	Mature, influenced by stewardship policies	~USD 400	Resistance management
Europe	Similar to US, increasing generics	~USD 350	Generic penetration
Asia-Pacific	High growth potential, emerging markets	~USD 150	Hospital expansion
Rest of World	Limited access, vaccine linkage	~USD 100	Infrastructure development

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9. Key Considerations for Stakeholders

• Pharmaceutical companies: Need to balance patent strategies with generics' market entry.
• Healthcare providers: Must assess resistance trends, stewardship, and formulary preferences.
• Payers: Focus on cost-effectiveness amid shifting resistance profiles.
• Investors: Monitor pipeline development and alternate spectrum antibiotics.

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10. Future Outlook and Innovation Horizons

Aspect	Outlook	Potential Impact
New Formulations	Extended-release or oral options	Increased compliance, expanded use
Combination Therapies	Combating resistance	Market niche expansion
Diagnostic Tools	Precision prescribing	Optimized use, resistance mitigation
Policy & Stewardship	Stricter regulations	May constrain volume but sustain premium pricing for niche uses

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Key Takeaways

• Patent expiry significantly impacted INVANZ's market share, necessitating strategic focus on volume and cost control.
• Generic competition now dominates, compressing margins but expanding access.
• Resistance development remains a critical concern, influencing prescribing patterns and limiting growth.
• Future growth hinges on innovations in formulations, combination therapies, and targeted usage.
• Emerging markets present considerable upside, especially with healthcare infrastructure improvements.

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FAQs

Q1: What is the primary driver behind INVANZ's declining revenue post-2018?
A: Patent expiration led to a surge in generic competition, resulting in reduced pricing and market share.

Q2: How does antibiotic resistance influence INVANZ's market prospects?
A: Rising resistance limits its use in certain infections, constraining growth. Conversely, resistance trends also create demand for newer or combination therapies.

Q3: Are there any ongoing developments or pipeline drugs related to eravapenem?
A: As of 2023, there are no significant pipeline innovations or formulations announced by Pfizer targeting eravapenem.

Q4: In which regions does INVANZ have the highest market penetration?
A: The U.S. and Europe hold the largest shares, driven by established hospital networks and reimbursement systems.

Q5: What strategies can manufacturers adopt to sustain revenue?
A: Focusing on developing niche indications, combining with other agents, expanding access in emerging markets, and innovating formulations.

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References

1. US Food and Drug Administration. INVANZ (Ertapenem Sodium) Prescribing Information, 2001.
2. IQVIA. Market Insight Report, 2022.
3. CDC Antibiotic Resistance Threats Report, 2021.
4. WHO Global Antimicrobial Resistance Surveillance System (GLASS), 2019.
5. CMS Reimbursement Policies, 2023.

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By understanding the evolving landscape that influences INVANZ’s market and financial trajectory, stakeholders can better strategize to optimize outcomes amid challenges such as patent cliff effects, resistance, and emerging competitors.