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.

Patents protecting TEFLARO

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	200327-001	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	200327-002	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/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
World Intellectual Property Organization (WIPO)	2011035305
Mexico	2012003411	COMPOSICIONES Y METODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA. (COMPOSITIONS AND METHODS FOR TREATING BACTERIAL INFECTIONS USING CEFTAROLINE.)
South Korea	100384047
Brazil	112012006250	composições e métodos para o tratamento de infecções bacterianas usando ceftaroline
Ukraine	110098	КОМПОЗИЦІЯ, ЩО МІСТИТЬ ЦЕФТАРОЛІН ФОЗАМІЛУ, ДЛЯ ЛІКУВАННЯ БАКТЕРІАЛЬНОЇ ІНФЕКЦІЇ
European Patent Office	1043327	DERIVES DE PHOSPHONOCEPHEM, LEUR PROCEDE DE PREPARATION ET LEUR UTILISATION (PHOSPHONOCEPHEM DERIVATIVES, PROCESS FOR THE PREPARATION OF THE SAME, AND USE THEREOF)
Eurasian Patent Organization	029149	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЦЕФТАРОЛИНА ФОЗАМИЛ, ДЛЯ ЛЕЧЕНИЯ БАКТЕРИАЛЬНЫХ ИНФЕКЦИЙ (PHARMACEUTICAL COMPOSITIONS COMPRISING CEFTAROLINE FOSAMIL FOR TREATING BACTERIAL INFECTIONS)

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	C300568	Netherlands		PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 00120823
1043327	1390003-0	Sweden		PRODUCT NAME: CEFTAROLINFOSAMIL; REG. 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	300568	Netherlands		PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	422	Finland
1043327	C01043327/01	Switzerland		PRODUCT NAME: CEFTAROLIN FOSAMIL; REGISTRATION NO/DATE: SWISSMEDIC 62672 29.08.2013