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Pemfexy is a drug marketed by Eagle Pharms and is included in one NDA. There are two patents protecting this drug.
This drug has twenty-five patent family members in fourteen countries.
The generic ingredient in PEMFEXY is pemetrexed. There are twenty-nine drug master file entries for this compound. Additional details are available on the pemetrexed profile page.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 28, 2035. This may change due to patent challenges or generic licensing.
There have been thirteen 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.
There are fifteen tentative approvals for the generic drug (pemetrexed), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
DrugPatentWatch® Estimated Generic Entry Opportunity Date for PEMFEXY
*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 PEMFEXY
Identify potential brand extensions & 505(b)(2) entrants
|Novartis Pharmaceuticals||Phase 3|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Eagle Pharms||PEMFEXY||pemetrexed||SOLUTION;INTRAVENOUS||209472-001||Feb 8, 2020||RX||Yes||Yes||Get Started for $10||Get Started for $10||Get Started for $10|
|Eagle Pharms||PEMFEXY||pemetrexed||SOLUTION;INTRAVENOUS||209472-001||Feb 8, 2020||RX||Yes||Yes||Get Started for $10||Get Started for $10||Y||Get Started for $10|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Country||Patent Number||Estimated Expiration|
|Taiwan||201619161||Get Started for $10|
|Slovenia||1313508||Get Started for $10|
|Denmark||1313508||Get Started for $10|
|Japan||2018197265||Get Started for $10|
|Germany||60127970||Get Started for $10|
|European Patent Office||3212193||Get Started for $10|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|0432677||7/2005||Austria||Get Started for $10||PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920|
|0432677||SPC/GB05/011||United Kingdom||Get Started for $10||PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|