CEFTAROLINE FOSAMIL - Generic Drug Details

What are the generic drug sources for ceftaroline fosamil and what is the scope of freedom to operate?

Ceftaroline fosamil is the generic ingredient in two branded drugs marketed by Apotex and Abbvie, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ceftaroline fosamil has twenty-nine patent family members in twenty-three countries.

There are two drug master file entries for ceftaroline fosamil. One supplier is listed for this compound.

Summary for CEFTAROLINE FOSAMIL

International Patents:	29
US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	28
Patent Applications:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CEFTAROLINE FOSAMIL
What excipients (inactive ingredients) are in CEFTAROLINE FOSAMIL?	CEFTAROLINE FOSAMIL excipients list
DailyMed Link:	CEFTAROLINE FOSAMIL at DailyMed

Recent Clinical Trials for CEFTAROLINE FOSAMIL

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

Sponsor	Phase
Poitiers University Hospital	Phase 1
Basim Asmar	Phase 1
AstraZeneca	Phase 2

See all CEFTAROLINE FOSAMIL clinical trials

Pharmacology for CEFTAROLINE FOSAMIL

Drug Class

Cephalosporin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for CEFTAROLINE FOSAMIL

J01DI	Other cephalosporins and penems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for CEFTAROLINE FOSAMIL

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 CEFTAROLINE FOSAMIL

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	9,629,861		Y
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes	8,247,400		Y
Apotex	CEFTAROLINE FOSAMIL	ceftaroline fosamil	POWDER;INTRAVENOUS	208075-001	Sep 21, 2021		DISCN	No	No
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	Yes	8,247,400		Y
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes	9,629,861		Y

Expired US Patents for CEFTAROLINE FOSAMIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010	7,419,973
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010	6,417,175
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010	6,417,175
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010	7,419,973
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010	6,906,055

EU/EMA Drug Approvals for CEFTAROLINE FOSAMIL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Ireland Pharmaceuticals	Zinforo	ceftaroline fosamil	EMEA/H/C/002252 Zinforo 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 CEFTAROLINE FOSAMIL

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	029149	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЦЕФТАРОЛИНА ФОЗАМИЛ, ДЛЯ ЛЕЧЕНИЯ БАКТЕРИАЛЬНЫХ ИНФЕКЦИЙ (PHARMACEUTICAL COMPOSITIONS COMPRISING CEFTAROLINE FOSAMIL FOR TREATING BACTERIAL INFECTIONS)
Dominican Republic	P2012000077	COMPOSICIONES Y METODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA
Australia	2010295269	Compositions and methods for treating bacterial infections using ceftaroline
Honduras	2012000585	COMPOSICIONES Y METODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA
Cuba	20120048	COMPOSICIONES Y MÉTODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA

Supplementary Protection Certificates for CEFTAROLINE FOSAMIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1043327	13C0008	France		PRODUCT NAME: CEFTAROLINE FOSAMIL, SES ESTERS OU SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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	C300568	Netherlands		PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 00120823
1043327	2013/001	Ireland		PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; 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

CEFTAROLINE FOSAMIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ceftaroline Fosamil

Introduction to Ceftaroline Fosamil

Ceftaroline fosamil, a prodrug of the active antibiotic ceftaroline, is a crucial treatment option for various bacterial infections, including acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired pneumonia (CAP). Here, we delve into the market dynamics and financial trajectory of this antibiotic.

Market Size and Growth

The global ceftaroline fosamil market has been experiencing significant growth. As of 2023, the market size was valued at several million dollars, with a projected compound annual growth rate (CAGR) from 2024 to 2031[1][4].

Regional Analysis

The market is segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region contributes significantly to the overall revenue, with varying growth rates and market shares. For instance, the North American and European markets are among the largest due to high healthcare spending and the prevalence of bacterial infections[1].

Competitive Landscape

The ceftaroline fosamil market is dominated by several key players, including Roche, Pfizer, Abbvie, Johnson & Johnson, Sanofi, Merck, Novartis, Gilead, GSK, Amgen, and Hayao. These companies play a crucial role in driving market growth through their extensive distribution networks and research and development efforts[4].

Type and Application Segmentation

The market is segmented based on the type of ceftaroline fosamil and its applications. The drug is primarily used for treating ABSSSIs and CAP, among other bacterial infections. Understanding these segments helps in identifying the most lucrative areas for investment and growth[1].

Financial Impact and Cost-Effectiveness

Hospital Budget Impact

Adding ceftaroline fosamil to a hospital formulary can have a positive financial impact. Studies have shown that the total cost of care for treating a patient with an ABSSSI is lower with ceftaroline fosamil compared to other treatments like vancomycin plus aztreonam or other vancomycin-containing regimens. For example, the estimated total cost of care was $395 lower with ceftaroline fosamil[2].

Healthcare Resource Use

Ceftaroline fosamil has been associated with reduced healthcare resource use. In patients with CAP, clinical response to ceftaroline fosamil resulted in a shorter length of ICU stay (3.6 versus 9.2 days) and lower hospital costs ($8,449 versus $12,559) compared to non-responders[5].

Development and Approval Costs

The development and approval costs for ceftaroline fosamil are relatively lower compared to other drug categories. Antimicrobial drugs, including ceftaroline fosamil, have an average capitalized development and approval cost of $1.508 billion, which is significantly lower than the costs for non-antimicrobial and oncology drugs[3].

Market Trends and Drivers

Increasing Prevalence of Bacterial Infections

The rising incidence of bacterial infections, particularly those resistant to traditional antibiotics, drives the demand for effective treatments like ceftaroline fosamil.

Regulatory Support

Regulatory bodies often support the development and approval of antimicrobial drugs due to their critical role in public health. This support can accelerate the market growth of ceftaroline fosamil.

Technological Advancements

Advancements in pharmacokinetics and pharmacodynamics have made ceftaroline fosamil more effective against common bacterial pathogens, enhancing its market appeal.

Challenges and Restraints

Resistance and Side Effects

The development of antibiotic resistance and potential side effects are significant challenges that can impact the long-term growth of the ceftaroline fosamil market.

High Development Costs

Although the development costs of antimicrobial drugs are lower compared to some other categories, they are still substantial and can be a barrier for new entrants in the market.

Market Attractiveness and Opportunities

Emerging Markets

Emerging markets in Asia Pacific and Latin America offer significant growth opportunities due to increasing healthcare spending and a growing need for effective antibiotic treatments.

Expanding Indications

Research into new indications for ceftaroline fosamil can expand its market potential beyond current uses.

SWOT Analysis

Strengths

• Effective treatment for ABSSSIs and CAP
• Lower healthcare costs compared to other treatments
• Strong distribution networks of key players

Weaknesses

• Potential for antibiotic resistance
• Side effects associated with the drug
• High development costs

Opportunities

• Growing demand in emerging markets
• Expanding indications for the drug
• Regulatory support for antimicrobial drugs

Threats

• Increasing competition from new antibiotics
• Economic constraints affecting healthcare spending
• Regulatory changes impacting market dynamics

Key Takeaways

• The global ceftaroline fosamil market is expected to grow significantly from 2024 to 2031, driven by increasing demand for effective antibiotic treatments.
• The drug is cost-effective and reduces healthcare resource use, making it an attractive option for hospitals.
• Key players dominate the market, but emerging markets and new indications offer growth opportunities.
• Challenges such as antibiotic resistance and side effects need to be addressed to sustain long-term growth.

FAQs

What is the current market size of ceftaroline fosamil?

The global ceftaroline fosamil market size was valued at several million dollars in 2023, with a projected growth from 2024 to 2031[1][4].

Who are the main players in the ceftaroline fosamil market?

The main players include Roche, Pfizer, Abbvie, Johnson & Johnson, Sanofi, Merck, Novartis, Gilead, GSK, Amgen, and Hayao[4].

How does ceftaroline fosamil impact hospital budgets?

Ceftaroline fosamil can lower the total cost of care for treating patients with ABSSSIs by $395 compared to other treatments[2].

What are the key drivers of the ceftaroline fosamil market?

Key drivers include the increasing prevalence of bacterial infections, regulatory support, and technological advancements in pharmacokinetics and pharmacodynamics.

What are the potential challenges for the ceftaroline fosamil market?

Challenges include the development of antibiotic resistance, potential side effects, and high development costs[3].

Sources

1. Cognitivemarketresearch.com: Ceftaroline Fosamil Market Report 2024 (Global Edition)
2. PubMed: Ceftaroline fosamil use in hospitalized patients with acute bacterial skin and skin structure infections
3. ASPE: Antimicrobial Drugs Market Returns Analysis
4. Valuates.com: Global Ceftaroline Fosamil Market Research Report 2024
5. Oxford Academic: Ceftaroline fosamil treatment patterns and outcomes in adults with community-acquired pneumonia