CEFTAROLINE FOSAMIL Drug Patent Profile
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When do Ceftaroline Fosamil patents expire, and when can generic versions of Ceftaroline Fosamil launch?
Ceftaroline Fosamil is a drug marketed by Apotex and is included in one NDA.
The generic ingredient in CEFTAROLINE FOSAMIL is ceftaroline fosamil. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ceftaroline fosamil profile page.
Summary for CEFTAROLINE FOSAMIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| 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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | CEFTAROLINE FOSAMIL | ceftaroline fosamil | POWDER;INTRAVENOUS | 208075-001 | Sep 21, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | CEFTAROLINE FOSAMIL | ceftaroline fosamil | POWDER;INTRAVENOUS | 208075-002 | Sep 21, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
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 |
