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Ceftaroline fosamil - Generic Drug Details

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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 one branded drug marketed by Allergan and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ceftaroline fosamil has sixty-nine 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:	69
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
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/Phase 3

See all ceftaroline fosamil clinical trials

Pharmacology for ceftaroline fosamil

Drug Class

Cephalosporin Antibacterial

Paragraph IV (Patent) Challenges for CEFTAROLINE FOSAMIL

Tradename	Dosage	Ingredient	NDA	Submissiondate
TEFLARO	POWDER;INTRAVENOUS	ceftaroline fosamil	200327	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	200327-002	Oct 29, 2010		RX	Yes	Yes			Y	Y
Allergan	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes			Y
Allergan	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	No			Y	Y
Allergan	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes			Y
Allergan	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	No			Y	Y
Allergan	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes			Y	Y

International Patents for ceftaroline fosamil

Country	Patent Number	Estimated Expiration
Peru	20171176
Guatemala	201200082
Israel	218349
Japan	3467418
European Patent Office	2480236
Colombia	6531417

Supplementary Protection Certificates for ceftaroline fosamil

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	300568	Netherlands		PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	CA 2013 00003	Denmark
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
1043327	422	Finland