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 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
PRA Health Sciences	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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Apotex	CEFTAROLINE FOSAMIL	ceftaroline fosamil	POWDER;INTRAVENOUS	208075-002	Sep 21, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Apotex	CEFTAROLINE FOSAMIL	ceftaroline fosamil	POWDER;INTRAVENOUS	208075-001	Sep 21, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CEFTAROLINE FOSAMIL

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

EU/EMA Drug Approvals for CEFTAROLINE FOSAMIL

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for CEFTAROLINE FOSAMIL

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Country	Patent Number	Title	Estimated Expiration
Colombia	6531417	COMPOSICIONES Y MÉTODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA	⤷ Sign Up
Peru	20171176	COMPOSICIONES Y METODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA	⤷ Sign Up
Peru	20121819	COMPOSICIONES Y METODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA	⤷ Sign Up
New Zealand	717866	Compositions and methods for treating bacterial infections using ceftaroline	⤷ Sign Up
Ecuador	SP12011739	COMPOSICIONES Y MÉTODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA	⤷ Sign Up
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)	⤷ Sign Up
Australia	2010295269	Compositions and methods for treating bacterial infections using ceftaroline	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CEFTAROLINE FOSAMIL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1043327	13C0008	France	⤷ Sign Up	PRODUCT NAME: CEFTAROLINE FOSAMIL, SES ESTERS OU SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	SPC/GB13/004	United Kingdom	⤷ Sign Up	PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/12/785/001 20120823
1043327	92134	Luxembourg	⤷ Sign Up	PRODUCT NAME: CEFTAROLINE FOSAMIL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ZINFORO)
1043327	2013/001	Ireland	⤷ Sign Up	PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	C300568	Netherlands	⤷ Sign Up	PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 00120823
1043327	300568	Netherlands	⤷ Sign Up	PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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