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Ceftaroline fosamil - Generic Drug Details

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What are the generic sources for ceftaroline fosamil and what is the scope of ceftaroline fosamil freedom to operate?

Ceftaroline fosamil is the generic ingredient in one branded drug marketed by Allergan Sales Llc 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-seven patent family members in thirty-two countries.

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

Summary for ceftaroline fosamil

International Patents:	67
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	15
Clinical Trials:	28
Patent Applications:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ceftaroline fosamil
DailyMed Link:	ceftaroline fosamil at DailyMed

Pharmacology for ceftaroline fosamil

Drug Class

Cephalosporin Antibacterial

Synonyms for ceftaroline fosamil

(6R,7R)-7-(((2Z)-(Ethoxyimino)(5-(phosphonoamino)-1,2,4-thiadiazol-3-yl)acetyl)amino)-3-((4-(1-methylpyridinium-4-yl)thiazol-2-yl)sulfanyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-2-carboxylate monoacetate monohydrate

(6R,7R)-7-({(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetyl}amino)-3-{[4-(1-methylpyridinium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

(6R,7R)-7-[(2Z)-2-ethoxyimino-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetyl]amino]-3-[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

1134503-56-2

1210978-33-8

1442644-01-0

229016-73-3

4-(2-{[(6R,7R)-2-carboxy-7-[(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]sulfanyl}-1,3-thiazol-4-yl)-1-methylpyridin-1-ium acetate hydrate

400827-46-5

400827-55-6

595568-96-0

7-({(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetyl}amino)-3-{[4-(1-methylpyridinium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-3,4-didehydrocepham-4-carboxylate

7P6FQA5D21

AKOS027326632

AKOS030623089

ceftarolina fosamilo

Ceftaroline fosamil (USAN/INN)

Ceftaroline fosamil [USAN:INN:BAN]

Ceftaroline fosamil acetate

Ceftaroline Fosamil Acetate [USAN]

Ceftaroline fosamil acetate anhydrous

Ceftaroline fosamil acetate hydrate

Ceftaroline fosamil acetate monohydrate

Ceftaroline Fosamil hydrate

Ceftaroline inner salt

ceftarolinum fosamilum

CHEBI:70714

CHEBI:70718

CHEMBL3544973

CHEMBL501122

CS-2823

D08884

DB06590

DTXSID10193134

DTXSID50193133

DTXSID60177444

EZ9W6O5S09

HY-14737

P9VXV1408Y

PPI 0903

PPI-0903

PPI-0903 monoacetate monohydrate

Pyridinium, 4-(2-(((6R,7R)-2-carboxy-7-(((2Z)-(ethoxyimino)(5-(phosphonoamino)-1,2,4-thiadiazol-3-yl)acetyl)amino)-8-oxo-5-thia-1- azabicyclo(4.2.0)oct-2-en-3-yl)thio)-4-thiazolyl)-1-methyl-, acetate

Pyridinium, 4-(2-(((6R,7R)-2-carboxy-7-(((2Z)-2-(ethoxyimino)-1-oxo-2-(5-(phosphonoamino)-1,2,4-thiadiazol-3-yl)ethyl)amino)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)thio)-4-thiazolyl)-1-methyl-, inner salt

SCHEMBL1464037

SCHEMBL1690569

TAK 599 monoacetate monohydrate

TAK-599

Teflaro

Teflaro (TN)

UNII-7P6FQA5D21

UNII-EZ9W6O5S09

UNII-P9VXV1408Y

Zinforo

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 Sales Llc	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	No			Y	Y
Allergan Sales Llc	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	No			Y
Allergan Sales Llc	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	No
Allergan Sales Llc	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes			Y
Allergan Sales Llc	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-002	Oct 29, 2010		RX	Yes	Yes			Y	Y
Allergan Sales Llc	TEFLARO	ceftaroline fosamil	POWDER;INTRAVENOUS	200327-001	Oct 29, 2010		RX	Yes	No			Y

International Patents for ceftaroline fosamil

Country	Patent Number	Estimated Expiration
South Korea	100384047
Honduras	2012000585
Japan	H11255772
Australia	1683299
Canada	2418614
Guatemala	201200082

Supplementary Protection Certificates for ceftaroline fosamil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1043327	C300568	Netherlands		PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 00120823
1043327	13C0008	France		PRODUCT NAME: CEFTAROLINE FOSAMIL, SES ESTERS OU SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327	1390003-0	Sweden		PRODUCT NAME: CEFTAROLINFOSAMIL; REG. NO/DATE: EU/1/12/785/001 20120823
1043327	C01043327/01	Switzerland		PRODUCT NAME: CEFTAROLIN FOSAMIL; REGISTRATION NO/DATE: SWISSMEDIC 62672 29.08.2013
1043327	CA 2013 00003	Denmark
1043327	SPC/GB13/004	United Kingdom		PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/12/785/001 20120823