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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

Last Updated: November 24, 2020

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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. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for pralatrexate

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

Changchun DengPhase 1
BayerPhase 1
University of Alabama at BirminghamEarly Phase 1

See all pralatrexate clinical trials

Generic filers with tentative approvals for PRALATREXATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MG/2MLINJECTABLE;INJECTION
  Start Trial  Start 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.

Pharmacology for pralatrexate
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 022468-001 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

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.