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 Allergan, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ceftaroline fosamil has fifty-two patent family members in thirty-four countries.

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

Summary for ceftaroline fosamil

International Patents:	52
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
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
PRA Health Sciences	Phase 2

See all ceftaroline fosamil clinical trials

Pharmacology for ceftaroline fosamil

Drug Class

Cephalosporin Antibacterial

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
Allergan	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	Yes			Y	Y
Apotex	CEFTAROLINE FOSAMIL	ceftaroline fosamil	POWDER;INTRAVENOUS	208075-001	Sep 21, 2021		DISCN	No	No
Allergan	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes			Y

Expired US Patents for ceftaroline fosamil

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

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
Japan	2009114202	PHOSPHONOCEPHEM DERIVATIVE, METHOD FOR PRODUCING THE SAME, AND USE THEREOF
Taiwan	473479
European Patent Office	2480236	COMPOSITIONS ET PROCÉDÉS POUR TRAITER DES INFECTIONS BACTÉRIENNES À L'AIDE DE CEFTAROLINE (COMPOSITIONS AND METHODS FOR TREATING BACTERIAL INFECTIONS USING CEFTAROLINE)

Supplementary Protection Certificates for ceftaroline fosamil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1043327	92134	Luxembourg		PRODUCT NAME: CEFTAROLINE FOSAMIL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ZINFORO)
1043327	CA 2013 00003	Denmark
1043327	422	Finland