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Last Updated: May 26, 2022

Pralatrexate - Generic Drug Details


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What are the generic 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.

Recent Clinical Trials for pralatrexate

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

SponsorPhase
Otsuka Pharmaceutical Development & Commercialization, Inc.Phase 1
University of BolognaPhase 1
Merck Sharp & Dohme Corp.Phase 1

See all pralatrexate clinical trials

Pharmacology for pralatrexate
Paragraph IV (Patent) Challenges for PRALATREXATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FOLOTYN Injection pralatrexate 20 mg/mL and 40 mg/2 mL 022468 4 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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for pralatrexate

Country Patent Number Title Estimated Expiration
Germany 602005009176 See Plans and Pricing
Austria 405272 See Plans and Pricing
China 1960734 Treatment of t-cell lymphoma using 10-propargyl-10-deazaaminopterin See Plans and Pricing
Germany 69738981 See Plans and Pricing
Brazil PI0510895 formulação farmacêutica de 10-propargila-10-deazaaminopterina para tratamento de linfoma de célula t See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
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Mallinckrodt
Colorcon
Baxter

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