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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.
Summary for CEFTAROLINE FOSAMIL
| International Patents: | 69 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 33 |
| Clinical Trials: | 28 |
| Patent Applications: | 217 |
| 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/Phase 3 |
Pharmacology for CEFTAROLINE FOSAMIL
| Drug Class | Cephalosporin Antibacterial |
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 | 200327-001 | 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 | Y | 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 | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for CEFTAROLINE FOSAMIL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112012006250 | Start Trial |
| Cyprus | 1109313 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9932497 | Start Trial |
| Chile | 2012000694 | Start Trial |
| >Country | >Patent Number | >Estimated 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 | 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 | CA 2013 00003 | Denmark | Start Trial | |
| 1043327 | C01043327/01 | Switzerland | Start Trial | PRODUCT NAME: CEFTAROLIN FOSAMIL; REGISTRATION NO/DATE: SWISSMEDIC 62672 29.08.2013 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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