teflaro Drug Patent Profile

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

Teflaro is a drug marketed by Abbvie and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-nine patent family members in twenty-three countries.

The generic ingredient in TEFLARO is ceftaroline fosamil. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ceftaroline fosamil profile page.

DrugPatentWatch^® Generic Entry Outlook for Teflaro

Teflaro was eligible for patent challenges on October 29, 2014.

There have been three patent litigation cases 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 teflaro

International Patents:	29
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	12
Drug Prices:	Drug price information for teflaro
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for teflaro
What excipients (inactive ingredients) are in teflaro?	teflaro excipients list
DailyMed Link:	teflaro at DailyMed

See drug prices for teflaro

Recent Clinical Trials for teflaro

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

Sponsor	Phase
Olayemi Osiyemi MD	Phase 4
Basim Asmar	Phase 1
Sharp HealthCare	Phase 4

See all teflaro clinical trials

Pharmacology for teflaro

Drug Class

Cephalosporin Antibacterial

Paragraph IV (Patent) Challenges for TEFLARO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEFLARO	for Injection	ceftaroline fosamil	400 mg/vial and 600 mg/vial	200327	2	2014-10-29

US Patents and Regulatory Information for teflaro

teflaro is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	Yes			Y
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes			Y
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	Yes			Y
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes			Y

Expired US Patents for teflaro

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010

EU/EMA Drug Approvals for teflaro

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Ireland Pharmaceuticals	Zinforo	ceftaroline fosamil	EMEA/H/C/002252Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults:, , , Complicated skin and soft tissue infections (cSSTI), Community-acquired pneumonia (CAP), , , Consideration should be given to official guidance on the appropriate use of antibacterial agents.,	Authorised	no	no	no	2012-08-22

International Patents for teflaro

When does loss-of-exclusivity occur for teflaro?

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

Canada

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 teflaro around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2323759
Denmark	1310502
Japan	2009114202	PHOSPHONOCEPHEM DERIVATIVE, METHOD FOR PRODUCING THE SAME, AND USE THEREOF
World Intellectual Property Organization (WIPO)	2011035305
Japan	H11255772	PHOSPHONOCEPHEM DERIVATIVE, ITS PRODUCTION AND USE THEREOF

Supplementary Protection Certificates for teflaro

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1043327	SPC/GB13/004	United Kingdom		PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/12/785/001 20120823
1043327	92134	Luxembourg		PRODUCT NAME: CEFTAROLINE FOSAMIL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ZINFORO)
1043327	2013/001	Ireland		PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	300568	Netherlands		PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	1390003-0	Sweden		PRODUCT NAME: CEFTAROLINFOSAMIL; REG. NO/DATE: EU/1/12/785/001 20120823

Market Dynamics and Financial Trajectory for Teflaro (Ceftaroline Fosamil)

Last updated: July 27, 2025

Introduction

Teflaro (Ceftaroline Fosamil) stands out as a broad-spectrum cephalosporin antibiotic approved by the U.S. Food and Drug Administration (FDA) in 2010. Its unique mechanism, including activity against methicillin-resistant Staphylococcus aureus (MRSA), positions it amidst a competitive landscape of antibiotics targeting serious bacterial infections. Analyzing Teflaro’s market dynamics and financial trajectory reveals insights into its current position, growth potential, challenges, and strategic opportunities within the pharmaceutical arena.

Market Overview and Demand Drivers

Rising Antimicrobial Resistance (AMR)

The global escalation of antimicrobial resistance significantly influences Teflaro's market prospects. With pathogens like MRSA and resistant Streptococcus species becoming prevalent, demand for advanced antibiotics like Teflaro increases. The CDC estimates that resistant bacteria cause over 2.8 million infections annually in the U.S., with approximately 35,000 deaths (CDC, 2021). As resistance renders traditional antibiotics ineffective, clinicians turn toward novel agents with proven efficacy against resistant strains, bolstering Teflaro’s usage.

Hospital-Acquired and Community-Onset Infections

Teflaro’s primary application in complicated skin and skin structure infections (cSSSI), community-acquired pneumonia (CAP), and acute bacterial skin and skin structure infections (ABSSSI) aligns with rising hospitalization rates for such conditions. The increasing prevalence of these infections, coupled with the need for effective empiric therapy, sustains product demand.

Clinical Validation and Usage Guidelines

Inclusion in clinical guidelines further solidifies Teflaro's position. For example, the Infectious Diseases Society of America (IDSA) recommends ceftaroline in specific scenarios involving MRSA or resistant pathogens, driving adoption among healthcare providers.

Competitive Landscape

Teflaro faces competition from other cephalosporins, carbapenems, and newer antibiotics with activity against resistant strains, such as linezolid, daptomycin, and ceftaroline’s own rivals. Furthermore, the advent of generic antibiotics and alternative therapies influences market share.

Financial Trajectory Analysis

Revenue Performance and Trends

Initially launched in 2010, Teflaro experienced gradual growth driven by expanding indications and institutional procurement. The product’s peak revenues, reported within early 2010s, reflected a combination of high institutional usage and limited competition.

From its 2019 peak, the market saw a plateau, impacted by several factors:

• Market Saturation: Over time, early adopters have integrated Teflaro into standard protocols.
• Competitive Pressures: Emergence of alternative antibiotics has constrained growth.
• Reimbursement Dynamics: Changes in hospital reimbursement policies influence prescribing patterns.

Impact of Patent and Regulatory Status

Teflaro’s patent protections have historically limited generic competition, allowing the original manufacturer, Allergan/Baxter (later acquired by Pfizer), to maintain premium pricing. However, as patent exclusivity period approaches expiration, the risk of generic entry looms, threatening revenue erosion.

Commercial Strategies and Market Penetration

Strategic initiatives such as expanding approved indications (e.g., community-acquired bacterial pneumonia) and geographic expansion into European and Asian markets can bolster revenue streams. Additionally, educational campaigns highlighting Teflaro’s unique efficacy against MRSA aid in market penetration.

Cost and Pricing Dynamics

Pricing strategies remain pivotal. Maintaining premium pricing sustains margins, yet cost containment and formulary positioning pressures hospital-based sales. Manufacturing costs, driven by complex synthesis processes and patent protections, influence profitability margins.

Challenges Impacting Market Dynamics

Antibiotic Stewardship and Prescribing Trends

Growing antibiotic stewardship programs aim to curb unnecessary antibiotic use to combat resistance, potentially reducing Teflaro’s prescriptions. Balancing appropriate use with market growth remains a strategic challenge.

Regulatory and Reimbursement Environment

Evolving regulatory requirements, especially around real-world evidence submissions and post-marketing surveillance, influence market access. Reimbursement policies, particularly in negotiated hospital drug formularies, can restrict Teflaro’s utilization if alternative agents are favored.

Patent Expiration and Generic Competition

The impending patent expiration, projected within the next 2-3 years, risks significant revenue decline due to generic cefaroline formulations entering the market and compelling price reductions.

Supply Chain and Manufacturing Risks

Global supply chain disruptions, notably during the COVID-19 pandemic, affect production capacities, potentially leading to shortages that constrain availability and sales.

Growth Opportunities and Strategic Outlook

Geographic Expansion

Targeting emerging markets with rising healthcare infrastructure and antibiotic resistance issues presents a substantial growth avenue. Strategic partnerships and local regulatory approvals can accelerate market entry.

Expanded Indications and Combination Therapies

Clinical trials assessing Teflaro’s efficacy in additional infections or in combination with other agents can extend its therapeutic reach, thereby driving growth.

Formulary and Institutional Adoption

Building relationships with key hospital formularies and healthcare systems is crucial. Demonstrating cost-effectiveness and favorable clinical outcomes will enhance adoption.

Innovation and Pipeline Development

Investment in formulation improvements, such as oral formulations, or novel delivery systems, can differentiate Teflaro and address unmet clinical needs.

Conclusion

Teflaro’s prospects are shaped primarily by rising AMR, clinical guideline endorsement, and strategic positioning against competitors. While current market performance remains stable, imminent patent expiry and evolving healthcare dynamics necessitate proactive adaptation. Investment in geographic expansion, indication diversification, and stakeholder engagement will be critical for sustaining its financial trajectory.

Key Takeaways

• Growing Need for Advanced Antibiotics: Antimicrobial resistance elevates demand for drugs like Teflaro, particularly for MRSA infections.
• Patent Expiry Risks: Approaching patent expiration threatens revenue streams from proprietary pricing.
• Market Saturation and Competition: Increased competition and formulary restrictions slow growth despite clinical advantages.
• Expansion Strategies: Geographical diversification and added indications can counteract consolidation and generic entry impacts.
• Regulatory and Reimbursement Context: Ongoing policy evolution requires adaptive strategies for market access and profitability.

FAQs

1. What are the main therapeutic indications for Teflaro?
Teflaro is primarily indicated for the treatment of complicated skin and skin structure infections (cSSSI), community-acquired pneumonia (CAP), and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible strains, including MRSA.

2. How does Teflaro compare to other antibiotics targeting resistant pathogens?
Teflaro offers unique activity against MRSA within the cephalosporin class. Its enhanced spectrum extends to certain resistant Streptococcus and Enterobacteriaceae spp., positioning it favorably compared to traditional cephalosporins lacking MRSA coverage.

3. What are the key risks to Teflaro’s future market performance?
Major risks include patent expiration leading to generic competition, shifts towards antibiotic stewardship limiting prescriptions, regulatory hurdles, and increasing competition from newer agents.

4. How can the manufacturer capitalize on upcoming opportunities?
Expanding into emerging markets, pursuing additional indications through clinical research, developing formulations suitable for outpatient use, and reinforcing clinician education are strategic pathways.

5. What role does antimicrobial stewardship play in Teflaro’s market trajectory?
Stewardship programs aim to optimize antibiotic use, potentially reducing inappropriate prescriptions, which could limit Teflaro’s growth but also ensures its use remains targeted and justified in resistant infections.

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Sources:
[1] Centers for Disease Control and Prevention (CDC), 2021. Antibiotic Resistance Threats in the United States.
[2] FDA, 2010. Teflaro (ceftaroline fosamil) approval announcement.
[3] Market Analysis Reports, 2022. Global Antibiotic Market Trends.
[4] IDSA Guidelines, 2019. Management of MRSA Infections.