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Last Updated: October 26, 2020

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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.

Recent Clinical Trials for ceftaroline fosamil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Poitiers University HospitalPhase 1
Basim AsmarPhase 1
PRA Health SciencesPhase 2/Phase 3

See all ceftaroline fosamil clinical trials

Pharmacology for ceftaroline fosamil
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 200327-001 Oct 29, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ceftaroline fosamil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1043327 92134 Luxembourg   Start Trial PRODUCT NAME: CEFTAROLINE FOSAMIL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ZINFORO)
1043327 422 Finland   Start Trial
1043327 C01043327/01 Switzerland   Start Trial PRODUCT NAME: CEFTAROLIN FOSAMIL; REGISTRATION NO/DATE: SWISSMEDIC 62672 29.08.2013
1043327 2013/001 Ireland   Start Trial PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327 C300568 Netherlands   Start Trial PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 00120823
1043327 1390003-0 Sweden   Start Trial PRODUCT NAME: CEFTAROLINFOSAMIL; REG. NO/DATE: EU/1/12/785/001 20120823
1043327 13C0008 France   Start Trial PRODUCT NAME: CEFTAROLINE FOSAMIL, SES ESTERS OU SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
McKesson
Johnson and Johnson
Moodys
Merck

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