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Last Updated: September 22, 2021

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Pralatrexate - Generic Drug Details

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What are the generic drug sources for pralatrexate and what is the scope of freedom to operate?

Pralatrexate is 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. There is one tentative approval for this compound.

Summary for pralatrexate
Recent Clinical Trials for pralatrexate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Food and Drug Administration (FDA)Phase 2
University of VirginiaPhase 2
CelgenePhase 2

See all pralatrexate clinical trials

Generic filers with tentative approvals for PRALATREXATE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial40MG/2MLINJECTABLE;INJECTION
⤷  Free Forever Trial⤷  Free Forever Trial20MG/1MLINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for PRALATREXATE
Tradename Dosage Ingredient NDA Submissiondate
FOLOTYN SOLUTION;INTRAVENOUS pralatrexate 022468 2013-09-24

US Patents and Regulatory Information for pralatrexate

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 022468-002 Sep 24, 2009 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Johnson and Johnson
AstraZeneca
Colorcon
Express Scripts

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