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Last Updated: December 11, 2024

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 Biopharma and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pralatrexate has thirty-one patent family members in twenty-three countries.

There are two drug master file entries for pralatrexate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for pralatrexate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pralatrexate
Generic Entry Date for pralatrexate*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*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 pralatrexate

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

SponsorPhase
Acrotech Biopharma Inc.Phase 3
University of BolognaPhase 1
Merck Sharp & Dohme Corp.Phase 1

See all pralatrexate clinical trials

Generic filers with tentative approvals for PRALATREXATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up40MG/2MLINJECTABLE;INJECTION
⤷  Sign Up⤷  Sign Up20MG/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 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 Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for pralatrexate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Allos Therapeutics Ltd Folotyn pralatrexate EMEA/H/C/002096
treatment of peripheral T-cell lymphoma,
Refused no no yes 2012-06-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for pralatrexate

Country Patent Number Title Estimated Expiration
Montenegro 01087 TRETMAN LIMFOMA T-ĆELIJA PRIMJENOM 10-PROPARGIL-10-DEAZAAMINOPTERINA (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2005117892 ⤷  Sign Up
Australia 2005249516 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin ⤷  Sign Up
New Zealand 576849 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin salts ⤷  Sign Up
China 1960734 Treatment of t-cell lymphoma using 10-propargyl-10-deazaaminopterin ⤷  Sign Up
New Zealand 551082 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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