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Last Updated: February 25, 2024

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
Recent Clinical Trials for ceftaroline fosamil

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

SponsorPhase
Poitiers University HospitalPhase 1
Basim AsmarPhase 1
AstraZenecaPhase 2

See all ceftaroline fosamil clinical trials

Pharmacology for ceftaroline fosamil
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
Abbvie TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

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

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

International Patents for ceftaroline fosamil

Country Patent Number Title Estimated Expiration
Colombia 6531417 COMPOSICIONES Y MÉTODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA ⤷  Try a Trial
Canada 2774772 COMPOSITIONS ET PROCEDES POUR TRAITER DES INFECTIONS BACTERIENNES A L'AIDE DE CEFTAROLINE (COMPOSITIONS AND METHODS FOR TREATING BACTERIAL INFECTIONS USING CEFTAROLINE) ⤷  Try a Trial
Mexico 2012003411 COMPOSICIONES Y METODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA. (COMPOSITIONS AND METHODS FOR TREATING BACTERIAL INFECTIONS USING CEFTAROLINE.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ceftaroline fosamil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1043327 SPC/GB13/004 United Kingdom ⤷  Try a Trial PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/12/785/001 20120823
1043327 2013/001 Ireland ⤷  Try a Trial PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327 13C0008 France ⤷  Try a 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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