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
International Patents: | 52 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 44 |
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 |
Pharmacology for ceftaroline fosamil
Drug Class | Cephalosporin Antibacterial |
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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