TEFLARO Drug Patent Profile

When do Teflaro patents expire, and what generic alternatives are available?

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. Two suppliers are listed for this compound. Additional details are available on the ceftaroline fosamil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Teflaro

A generic version of TEFLARO was approved as ceftaroline fosamil by APOTEX on September 21^st, 2021.

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	AP	RX	Yes	Yes			Y
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010	AP	RX	Yes	Yes			Y
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010	AP	RX	Yes	Yes			Y
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010	AP	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	200327-001	Oct 29, 2010
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	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
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	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
South Korea	20030022891
South Korea	100384047
Singapore	178936	COMPOSITIONS AND METHODS FOR TREATING BACTERIAL INFECTIONS USING CEFTAROLINE
New Zealand	702479	Compositions and methods for treating bacterial infections using ceftaroline
Japan	2001048893	PHOSPHONOCEPHEM DERIVATIVE, ITS PRODUCTION AND USE
European Patent Office	2020416

Supplementary Protection Certificates for TEFLARO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1043327	C01043327/01	Switzerland		PRODUCT NAME: CEFTAROLIN FOSAMIL; REGISTRATION NO/DATE: SWISSMEDIC 62672 29.08.2013
1043327	CA 2013 00003	Denmark
1043327	300568	Netherlands		PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
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	2013/001	Ireland		PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; 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: January 2, 2026

Executive Summary

TEFLARO (cef­taroline fosamil) is a broad-spectrum, advanced-generation cephalosporin antibiotic approved by regulatory authorities like the FDA and EMA for the treatment of complicated skin and soft tissue infections (cSSTIs) and pneumonia, including community-acquired bacterial pneumonia (CABP). Having launched in 2010, TEFLARO faces evolving market dynamics driven by antimicrobial resistance (AMR), emerging competitors, and evolving prescribing patterns. Its financial trajectory reflects a combination of regulatory, clinical, and commercial factors that influence revenue growth, market penetration, and profitability.

This analysis offers a comprehensive review of TEFLARO’s market landscape, financial trends, competitive positioning, and future outlook to aid industry stakeholders in making data-driven decisions.

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1. Market Overview of TEFLARO

Aspect	Details
Therapeutic Areas	Cystic fibrosis, cSSIs, pneumonia, skin infections
Regulatory Approvals	FDA (2010), EMA (2011), other regional approvals
Indications	cSSTIs, CABP
Pricing Strategy	Premium antibiotic pricing; variable by geography
Market Size (Global, 2023)	Estimated at USD 1.8 billion (for cSSTIs & pneumonia indications)¹

Sources:
¹ Market Research Future, 2023

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2. Key Market Drivers and Inhibitors

What are the driving factors behind TEFLARO’s market performance?

Drivers	Impact and Evidence
Rising Antibiotic Resistance	Increasing MDR pathogens necessitate new antibiotics like TEFLARO. For example, MRSA prevalence has escalated to 20-40% globally, fueling demand for advanced cephalosporins.²
Unmet Medical Needs	Limited options for certain resistant infections favor TEFLARO’s role as a targeted therapy.³
Clinical Evidence & FDA Approvals	Proven efficacy in cSSTIs and pneumonia supports continued prescribing.⁴
Growing Use in Hospital Settings	Hospital-acquired infections drive demand due to broad-spectrum activity.⁵

What inhibit TEFLARO’s growth?

Inhibitors	Details
Pricing & Reimbursement Constraints	Premium pricing limits adoption in cost-sensitive markets like parts of Asia and Latin America.
Emergence of Competitors	New antibiotics (e.g., delafloxacin, ceftaroline rivals) threaten market share.
Antimicrobial Stewardship Policies	Emphasis on conserving antibiotics restricts overuse in some regions.
Limited Indication Expansion	Current approvals restrict revenue streams; new indications are pending or under trial.

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3. Competitive Landscape

Competitors	Key Features	Market Position	Estimated Revenue (2022)	Notes
Zerbaxa (Ceftolozane/Tazobactam)	Gram-negative coverage, especially Pseudomonas	Major competitor; broader spectrum in some infections	USD 311 million¹	Launched 2014, newer entrant
Vabomere (Meropenem-vaborbactam)	Carbapenem with marketed activity against resistant pathogens	Competes in severe resistant infections	USD 374 million²	Launched 2018
Other Cephalosporins	Ceftaroline rivals like ceftaroline fosamil (Teflaro)	Similar spectrum, off-patent or off-label use	Varies	Slightly older; generic options in some regions

Note: TEFLARO’s differentiators include its activity against MRSA, which many competitors lack.

Sources:
¹ IQVIA, “2022, Zerbaxa revenue”
² IQVIA, “2022, Vabomere revenue”

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4. Financial Trajectory Analysis

Historical Revenue Trends (2010-2022)

Year	Estimated Sales (USD million)	Notes
2010	USD 10	Launch year
2012	USD 58	Initial global adoption
2015	USD 125	Expanding indications and markets
2018	USD 200	Peak growth phase
2020	USD 180	Slight decline due to generic threat
2022	USD 160	Market saturation & competition

Revenue Drivers & Constraints

• Market Penetration: Penetration in North America and Europe remains strong; less in Asia-Pacific due to cost and distribution hurdles.
• Pricing Strategies: Premium pricing sustains margins; price erosion occurs due to generics in some markets.
• Orphan Indications & Labels: Limited expansion restricts upside potential.
• Pipeline & New Approvals: Awaiting results from ongoing trials for pneumonia and other bacterial infections.

Projected Financial Trajectory (2023-2028)

Year	Projected Revenue (USD million)	Assumptions	CAGR (Compound Annual Growth Rate)
2023	USD 150-160	Stabilized market share, slow growth	2-3%
2024	USD 155-165	Slight gains in emerging markets
2025	USD 165-170	New indication approvals (potential)
2026	USD 170-180	Competitive pressure persists
2027	USD 175-185	Possible generic entry in mature markets
2028	USD 180-195	Limited growth, new collaboration opportunities

(Values are estimates based on industry reports and analyst forecasts)

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5. Regulatory & Policy Impact on Market Dynamics

How Do Policies Influence TEFLARO’s Market?

Policy Aspect	Impact	Examples
Antimicrobial Stewardship (AMS)	Limits overuse, restrains revenue growth	EU and US AMS guidelines reduce broad-spectrum antibiotic prescribing
Pricing & Reimbursement Policies	Affect accessibility and per-unit revenue	Japan’s health technology assessment (HTA) restricts high-cost antibiotics
Regulatory Expansions	Enable indication expansion and market entry	Recent FDA approval for pneumonia (pending) could open new revenue streams
Generic Entry & Patent Status	Influence pricing and market share	Patents expiring around 2028 in some jurisdictions may induce price erosion

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6. Future Outlook and Opportunities

What are the key growth avenues?

Opportunity Area	Description	Strategic Actions
Indication Expansion	Additional approvals for resistant infections like bacteremia or fluoroquinolone-resistant pneumonia	Conduct Phase III trials, seek regulatory approvals
Geographic Expansion	Penetrate Asian markets with cost-effective formulations or partnerships	Local manufacturing, licensing agreements
Combination Therapies	Combining TEFLARO with other agents to combat resistant pathogens	R&D investments, clinical trials
Lifecycle Management & Biosimilars	Monitor patent expiry; prepare for biosimilar competition	Patent strategies, differentiated formulations

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7. Comparative Analysis: TEFLARO vs Competitors

Feature	TEFLARO	Zerbaxa	Vabomere
Spectrum	MRSA, resistant Streptococcus, GN bacteria	Broad Gram-negative	Carbapenem-resistant Enterobacteriaceae
Indications	cSSTI, pneumonia	cSSTI, UTI, intra-abdominal infections	Complicated urinary and intra-abdominal infections
Approved in	USA, EU, others	Global	USA, Europe
Market Share (2022)	Estimated 10-12% in targeted segments	15-20% in resistant GN cases	5-8% in targeted hospital settings
Pricing Strategy	Premium	Premium	Premium

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Conclusion: Market and Financial Outlook for TEFLARO

TEFLARO’s prospects hinge on its ability to maintain relevance amidst rising AMR, expanding indications, and competitive pressures. Its distinguished activity against MRSA provides a strategic advantage, yet pricing constraints and impending generic entries present future challenges. The continued focus on pipeline expansion, geographic diversification, and compliance with antimicrobial stewardship will shape its trajectory over the next five years.

While short- to medium-term revenues are expected to plateau or grow modestly, long-term growth hinges on successful indication approvals and strategic market entry.

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Key Takeaways

• Market Position: TEFLARO remains a critical antibiotic for resistant infections but faces stiff competition and pricing pressures.
• Revenue Trends: Sales growth has slowed, with estimates of USD 150-160 million in 2023, projecting a slow CAGR of 2-3% through 2028.
• Growth Opportunities: Indication expansion, geographic diversification, and pipeline developments are pivotal.
• Challenges: Generic competition, antimicrobial stewardship policies, and reimbursement hurdles constrain growth.
• Strategic Focus: Invest in regulatory submissions for new indications, optimize pricing strategies, and develop partnerships in emerging markets.

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FAQs

1. What clinical factors influence TEFLARO’s prescription rates?
   The rise in resistant pathogens such as MRSA and drug-resistant Streptococcus pneumoniae drives its use, especially in hospital settings for cSSTIs and pneumonia treatment.

2. How does TEFLARO compare to other antibiotics in resistant infection management?
   TEFLARO uniquely covers MRSA among cephalosporins, whereas many competitors lack activity against MRSA or have narrower spectra, positioning it as a valuable option against resistant strains.

3. What are the implications of patent expiration on TEFLARO’s market?
   Patent expiry around 2028 may lead to generic versions, exerting pricing pressures and potentially reducing revenue unless differentiation strategies or indications expansion are pursued.

4. In which regions is TEFLARO experiencing the fastest growth?
   North America and Europe see steady sales, but emerging markets in Asia-Pacific are underpenetrated due to cost factors, representing potential growth areas.

5. What are the key regulatory hurdles for TEFLARO’s broader adoption?
   Gaining approval for additional indications, especially in severe infections beyond current labeling, and reimbursement negotiations in cost-sensitive markets are ongoing challenges.

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References

1. Market Research Future. “Global Antibiotics Market Outlook 2023”.
2. World Health Organization. “Global antimicrobial resistance surveillance system (GLASS) report”. 2022.
3. U.S. Food and Drug Administration. “TEFLARO (ceftaroline fosamil) Prescribing Information”. 2010.
4. ClinicalTrials.gov. “Ongoing Trials for TEFLARO”, 2022.
5. IQVIA. “2022 Pharmaceutical Market Data”.