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. 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	8,247,400		Y
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes	9,629,861		Y
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

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	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
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010	6,906,055

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/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 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
European Patent Office	2080765
Mexico	2012003411	COMPOSICIONES Y METODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA. (COMPOSITIONS AND METHODS FOR TREATING BACTERIAL INFECTIONS USING CEFTAROLINE.)
Australia	2010295269	Compositions and methods for treating bacterial infections using ceftaroline
South Africa	201202924	COMPOSITIONS AND METHODS FOR TREATING BACTERIAL INFECTIONS USING CEFTAROLINE
South Korea	100384047
Japan	2002220395	PHOSPHONOCEPHEM COMPOUND

Supplementary Protection Certificates for TEFLARO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1043327	2013/001	Ireland		PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	13C0008	France		PRODUCT NAME: CEFTAROLINE FOSAMIL, SES ESTERS OU SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	CA 2013 00003	Denmark
1043327	422	Finland
1043327	300568	Netherlands		PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	92134	Luxembourg		PRODUCT NAME: CEFTAROLINE FOSAMIL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ZINFORO)

TEFLARO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Teflaro

Introduction to Teflaro

Teflaro, also known as ceftaroline fosamil, is a cephalosporin antibiotic that was introduced to the market in October 2010 by Forest Laboratories. It is notable for its efficacy against methicillin-resistant Staphylococcus aureus (MRSA), a significant challenge in healthcare settings due to its resistance to many commonly used antibiotics[1][4].

Approval and Indications

Teflaro was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible strains of indicated pathogens. This approval marked a significant milestone in the fight against MRSA and other resistant bacterial infections[1][4].

Market Positioning

Teflaro is positioned as a valuable addition to the antibiotic arsenal, particularly in the hospital setting where MRSA is a prevalent concern. Its ability to treat a range of bacterial infections with a high degree of safety and efficacy makes it a preferred choice for physicians. The drug's clinical-cure rates have been compared favorably to those of ceftriaxone, another widely used antibiotic[1].

Marketing Strategy

Forest Laboratories, the company behind Teflaro, implemented a robust marketing strategy to ensure the drug's successful launch. This included doubling the hospital-based field force from 110 to 220 representatives to enhance outreach and education among healthcare professionals. The marketing efforts highlighted Teflaro's unique advantages, such as its expanded activity against MRSA and its well-tolerated profile[1].

Financial Projections

At the time of its launch, analysts projected that Teflaro could achieve significant commercial success. Worldwide annual sales were estimated to reach a peak of $650 million, according to Decision Resources. However, some analysts noted potential limitations, such as the drug's inability to cover resistant gram-negative organisms and its status as an intravenous (I.V.) antibiotic with generic alternatives[1].

Market Performance

While specific financial data for Teflaro alone is not readily available, the broader context of the MRSA drugs market provides insight into its potential performance. The MRSA drugs market is projected to grow from $3.8 billion in 2023 to $5.5 billion by 2031, driven by the increasing prevalence of antibiotic-resistant infections and the need for effective treatment options. This growth trend suggests a favorable market environment for drugs like Teflaro[3].

Competitive Landscape

Teflaro operates in a competitive landscape where other antibiotics, including those from major pharmaceutical companies, are also vying for market share. For instance, ceftriaxone (Rocephin) is a well-established competitor, often referred to as "vitamin C" due to its widespread use in acute-care settings. However, Teflaro's unique activity against MRSA sets it apart and makes it a valuable option in the treatment of resistant infections[1].

Regulatory and Research Environment

The regulatory environment plays a crucial role in the development and marketing of antibiotics like Teflaro. Regulatory incentives and support are key drivers for pharmaceutical companies to invest in research and development of new antibiotics. The synergy between increasing healthcare expenditure and these regulatory incentives creates a favorable environment for the growth of the MRSA drugs market[3].

Clinical Efficacy and Safety

Teflaro has demonstrated strong clinical efficacy in treating CABP and ABSSSI, with cure rates comparable to those of ceftriaxone. The drug is generally well-tolerated, although it can cause adverse reactions such as GI upset, rash, and pseudomembranous colitis. Its safety profile is a significant factor in its market appeal, especially in a healthcare environment where patient safety is paramount[1][4].

Dosage and Administration

Teflaro is administered via I.V. infusion over one hour. The dosage varies based on the type of infection and the patient's renal function. For example, for patients with normal renal function, the recommended dose is 600 mg every 12 hours for 5-7 days for pneumonia and 5-14 days for skin and skin structure infections[1].

Future Outlook

The future outlook for Teflaro is tied to the broader trends in the MRSA drugs market. As healthcare systems continue to prioritize antimicrobial stewardship and patient care, the demand for innovative MRSA drugs is expected to grow. This growth, combined with ongoing research and development in the field, suggests that Teflaro will remain a relevant and valuable treatment option for resistant bacterial infections.

Key Statistics

• Market Size: The MRSA drugs market is projected to grow from $3.8 billion in 2023 to $5.5 billion by 2031[3].
• Growth Rate: The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.3%[3].
• Projected Sales: Teflaro's worldwide annual sales were estimated to reach a peak of $650 million[1].

Conclusion

Teflaro has carved out a significant niche in the antibiotic market due to its efficacy against MRSA and other resistant bacterial infections. Its strong clinical performance, favorable safety profile, and strategic marketing have positioned it as a valuable treatment option. As the MRSA drugs market continues to grow, Teflaro is likely to remain a key player, contributing to the broader efforts to combat antibiotic-resistant infections.

Key Takeaways

• Unique Efficacy: Teflaro is the first beta-lactam agent with clinically useful activity against MRSA.
• Market Growth: The MRSA drugs market is projected to grow significantly, driven by increasing healthcare expenditure and regulatory incentives.
• Clinical Performance: Teflaro has demonstrated strong clinical efficacy and a favorable safety profile.
• Marketing Strategy: Forest Laboratories implemented a robust marketing strategy to ensure the drug's successful launch.
• Future Outlook: Teflaro is expected to remain a relevant treatment option as healthcare systems prioritize antimicrobial stewardship.

FAQs

Q: What is Teflaro used for? A: Teflaro is used for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible strains of indicated pathogens[1].

Q: What makes Teflaro unique? A: Teflaro is the first beta-lactam agent with clinically useful activity against methicillin-resistant Staphylococcus aureus (MRSA)[4].

Q: How is Teflaro administered? A: Teflaro is administered via I.V. infusion over one hour, with dosages varying based on the type of infection and the patient's renal function[1].

Q: What are the potential side effects of Teflaro? A: Potential side effects include GI upset, rash, pseudomembranous colitis, and superinfection[1].

Q: What is the projected market size for MRSA drugs by 2031? A: The MRSA drugs market is projected to reach a valuation of $5.5 billion by 2031, growing at a CAGR of 4.3%[3].

Sources

1. MM+M - Medical Marketing and Media: Teflaro.
2. Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results: Allergan plc.
3. Verified Market Research: MRSA Drugs Market Size, Forecast.
4. Cleveland Clinic Journal of Medicine: Ceftaroline fosamil: A super-cephalosporin?
5. Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results: Allergan plc.