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Last Updated: January 30, 2023

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 Allergan, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ceftaroline fosamil has fifty-two 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
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

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
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Apotex CEFTAROLINE FOSAMIL ceftaroline fosamil POWDER;INTRAVENOUS 208075-001 Sep 21, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 See Plans and Pricing See Plans and Pricing
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 See Plans and Pricing See Plans and Pricing
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 See Plans and Pricing See Plans and Pricing
>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
Japan 2009114202 PHOSPHONOCEPHEM DERIVATIVE, METHOD FOR PRODUCING THE SAME, AND USE THEREOF See Plans and Pricing
Taiwan 473479 See Plans and Pricing
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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ceftaroline fosamil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1043327 92134 Luxembourg See Plans and Pricing PRODUCT NAME: CEFTAROLINE FOSAMIL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ZINFORO)
1043327 CA 2013 00003 Denmark See Plans and Pricing
1043327 422 Finland See Plans and Pricing
>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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