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Teflaro is a drug marketed by Allergan and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-nine patent family members in thirty-four countries.
The generic ingredient in TEFLARO 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.
Teflaro was eligible for patent challenges on October 29, 2014.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 10, 2031. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for TEFLARO
Generic Entry Opportunity Date for TEFLARO
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TEFLARO
Identify potential brand extensions & 505(b)(2) entrants
|Olayemi Osiyemi MD||Phase 4|
|Basim Asmar||Phase 1|
|Sharp HealthCare||Phase 4|
Pharmacology for TEFLARO
|Drug Class||Cephalosporin Antibacterial |
|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||Y||Start Trial|
|Allergan||TEFLARO||ceftaroline fosamil||POWDER;INTRAVENOUS||200327-002||Oct 29, 2010||RX||Yes||Yes||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|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1043327||SPC/GB13/004||United Kingdom||Start Trial||PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/12/785/001 20120823|
|1043327||92134||Luxembourg||Start Trial||PRODUCT NAME: CEFTAROLINE FOSAMIL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ZINFORO)|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|