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Pralatrexateis the generic ingredient in one branded drug marketed by Acrotech and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Pralatrexate has forty-four patent family members in twenty-three countries.
There are two drug master file entries for pralatrexate. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for pralatrexate
|Drug Master File Entries:||2|
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||60|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for pralatrexate|
|DailyMed Link:||pralatrexate at DailyMed|
Recent Clinical Trials for pralatrexate
Identify potential brand extensions & 505(b)(2) entrants
|Changchun Deng||Phase 1|
|University of Alabama at Birmingham||Early Phase 1|
Generic filers with tentative approvals for PRALATREXATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for pralatrexate
|Drug Class||Folate Analog Metabolic Inhibitor |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Acrotech||FOLOTYN||pralatrexate||SOLUTION;INTRAVENOUS||022468-001||Sep 24, 2009||RX||Yes||No||Start Trial||Start Trial||Y||Y||Start Trial|
|Acrotech||FOLOTYN||pralatrexate||SOLUTION;INTRAVENOUS||022468-002||Sep 24, 2009||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Acrotech||FOLOTYN||pralatrexate||SOLUTION;INTRAVENOUS||022468-001||Sep 24, 2009||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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